Activated platelets release a rich broth of growth factors involved in wound healing. One way to deliver activated platelets to wounds is in the form of platelet-rich plasma (PRP) harvested by centrifuging the patient's venous blood after activating the platelets with collagen or calcium chloride and/or autologous thrombin, then delicately removing the supernatant, called platelet-poor plasma (PPP). Platelet-rich plasma is usually injected into the lesion and/or applied topically, then sealed in or over the wound using a moisture-retentive dressing. Platelet-rich plasma (often with PPP) has been applied at different times, depths, and frequencies to chronic and acute wounds using various PRP doses and vehicles to achieve widely differing results. Meta-analyses have reported that PRP improved healing rates of open diabetic foot ulcers and venous ulcers and may reduce pain and surgical site infection (SSI) incidence in open and closed acute surgical wounds. However, inconsistency in study methods and outcome measures limited consistency of pain and SSI results. No consistent effect on healing or deep SSI rates was reported as a result of adding 1 intraoperative dose of PRP in the surgical site before closing elective foot and ankle surgery incisions of 250 patients as compared with 250 similar patients receiving the same procedure without PRP. After decades of research, ideal parameters of PRP delivery and use on each type of wound remain unclear for improving SSI, acute wound pain, and healing outcomes. This installment of the Evidence Corner reviews 2 surgical studies that may provide clues about optimal PRP use. One triple-blind randomized clinical trial (RCT) focused on irrigation of freshly closed carpal ligament surgical incisions with PRP as compared with PPP. Another non-blind RCT explored the effect of injecting PRP into open pilonidal sinus excisions 4 days and 12 days after surgery.

Background: While rapid healing of diabetic foot ulcers (DFUs) is highly desirable to avoid infections, amputations and life-threatening complications, DFUs often respond poorly to standard treatment. GMP-manufactured skin-derived ABCB5⁺ mesenchymal stem cells (MSCs) might provide a new adjunctive DFU treatment, based on their remarkable skin wound homing and engraftment potential, their ability to adaptively respond to inflammatory signals, and their wound healing-promoting efficacy in mouse wound models and human chronic venous ulcers.

Methods: The angiogenic potential of ABCB5⁺ MSCs was characterized with respect to angiogenic factor expression at the mRNA and protein level, in vitro endothelial trans-differentiation and tube formation potential, and perfusion-restoring capacity in a mouse hindlimb ischemia model. Finally, the efficacy and safety of ABCB5⁺ MSCs for topical adjunctive treatment of chronic, standard therapy-refractory, neuropathic plantar DFUs were assessed in an open-label single-arm clinical trial.

Results: Hypoxic incubation of ABCB5⁺ MSCs led to posttranslational stabilization of the hypoxia-inducible transcription factor 1α (HIF-1α) and upregulation of HIF-1α mRNA levels. HIF-1α pathway activation was accompanied by upregulation of vascular endothelial growth factor (VEGF) transcription and increase in VEGF protein secretion. Upon culture in growth factor-supplemented medium, ABCB5⁺ MSCs expressed the endothelial-lineage marker CD31, and after seeding on gel matrix, ABCB5⁺ MSCs demonstrated formation of capillary-like structures comparable with human umbilical vein endothelial cells. Intramuscularly injected ABCB5⁺ MSCs to mice with surgically induced hindlimb ischemia accelerated perfusion recovery as measured by laser Doppler blood perfusion imaging and enhanced capillary proliferation and vascularization in the ischemic muscles. Adjunctive topical application of ABCB5⁺ MSCs onto therapy-refractory DFUs elicited median wound surface area reductions from baseline of 59% (full analysis set, n = 23), 64% (per-protocol set, n = 20) and 67% (subgroup of responders, n = 17) at week 12, while no treatment-related adverse events were observed.

Conclusions: The present observations identify GMP-manufactured ABCB5⁺ dermal MSCs as a potential, safe candidate for adjunctive therapy of otherwise incurable DFUs and justify the conduct of a larger, randomized controlled trial to validate the clinical efficacy.

Trial registration: ClinicalTrials.gov, NCT03267784, Registered 30 August 2017, https://clinicaltrials.gov/ct2/show/NCT03267784.

We performed a meta-analysis to evaluate the effect of low-frequency ultrasound as an added treatment for chronic wounds. A systematic literature search up to May 2022 was performed and 838 subjects with chronic wounds at the baseline of the studies; 412 of them were using the low-frequency ultrasound (225 low-frequency high-intensity contact ultrasound for diabetic foot wound ulcers, and 187 low-frequency low-intensity non-contact ultrasound for a venous leg wound ulcers), and 426 were using standard care (233 sharp debridements for diabetic foot wound ulcers and 193 sham treatments for venous leg wound ulcers). Odds ratio (OR), and mean difference (MD) with 95% confidence intervals (CIs) were calculated to assess the effect of low-frequency ultrasound as an added treatment for chronic wounds using the dichotomous, and contentious methods with a random or fixed-effect model. The low-frequency high-intensity contact ultrasound for diabetic foot wound ulcers had significantly lower non-healed diabetic foot wound ulcers at ≥3 months (OR, 0.37; 95% CI, 0.24-0.56, P < .001), a higher percentage of diabetic foot wound ulcers area reduction (MD, 17.18; 95% CI, 6.62-27.85, P = .002) compared with sharp debridement for diabetic foot wound ulcers. The low-frequency low-intensity non-contact ultrasound for a venous leg wound ulcers had a significantly lower non-healed venous leg wound ulcers at ≥3 months (OR, 0.31; 95% CI, 0.15-0.62, P = .001), and higher percentage venous leg wound ulcers area reduction (MD, 18.96; 95% CI, 2.36-35.57, P = .03) compared with sham treatments for a venous leg wound ulcers. The low-frequency ultrasound as an added treatment for diabetic foot wound ulcers and venous leg wound ulcers had significantly lower non-healed chronic wound ulcers at ≥3 months, a higher percentage of chronic wound ulcers area reduction compared with standard care. The analysis of outcomes should be with caution because of the low sample size of all the 17 studies in the meta-analysis and a low number of studies in certain comparisons.

Background: It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003.

Objectives: To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents.

Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.

Selection criteria: Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area).

Data collection and analysis: Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.

Main results: Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life.

Authors' conclusions: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.

Purpose: This aim of this study was to evaluate the clinical efficacy of a self-managed cooling intervention in individuals with recently healed venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) on pain reduction and physical activity improvement.

Design: A 6-month longitudinal randomized controlled trial.

Subjects and setting: The sample comprised 140 individuals with previously healed VLU and DFU who received care in 3 outpatient wound centers in the Southeastern region of the United States. Participants were randomized to the MUSTCOOL or a placebo cooling patch intervention.

Methods: The cooling and placebo interventions comprised cooling or cotton-filled patch application to recently healed skin for 30 minutes, 3 times weekly plus standard of care including compression and leg elevation (participants with VLU) or therapeutic footwear and hygiene (participants with DFU) over a 6-month period. Pain severity and intensity were measured with the Brief Pain Inventory and physical activity with the International Physical Activity Questionnaire, which assessed metabolic equivalent of tasks (METs) in minutes per week. Minutes in walking time per week were assessed with an accelerometer. Data were descriptively analyzed for difference changes in scores from baseline to 6 months post-intervention.

Results: Data were analyzed for 81 participants randomized to cooling and placebo groups (VLUs, n = 26/29) and DFU (n = 12/16). Slight reductions in VLU pain severity (-0.5, -0.2) and interference (-0.4, -0.5) and minimal reductions in DFU pain severity (0, -0.1) and interference (0.4/0.1) were achieved. However, pain scores were low to moderate at baseline (mean 4, 0-10 with 10 worst pain possible) in both groups. For physical activity, the MET values showed low physical activity in both groups at baseline with slight improvements noted in VLU cooling and placebo groups (73/799) and DFU (1921/225), respectively. Walking time for the VLU groups improved by 1420/2523 minutes; the DFU groups improved 135/157 minutes, respectively. Findings for outcomes were not statistically significant within or between groups.

Conclusions: Application of the cooling pack compared to placebo was minimally efficacious in reducing posthealing pain and improving function in this posthealed ulcer population. However for pain, scores were initially low; thus outcomes on pain, while lower, were marginal.

Trial registration: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156), https://clinicaltrials.gov/ct2/show/NCT02626156 .

Objective: Recent preliminary reports indicate that extracorporeal shock wave therapy (ESWT) might be useful for chronic wounds, especially venous leg ulcers and diabetic foot ulcers. However, there is limited evidence for the utility and safety of ESWT in pressure ulcers (PUs). Therefore, this randomized controlled trial (RCT) aimed to assess immediate planimetric and clinical effects following a single radial ESWT session in PUs. Approach: A group of 40 patients with PUs was randomly assigned into 2 groups: active ESWT (n = 20), which underwent a single treatment with radial ESWT (300 + 100 impulses/1 cm², 2.5 bars, 0.15 mJ/mm², and 5 Hz) and placebo ESWT (n = 20), which was exposed to sham-radial ESWT. All patients continued standard wound care procedures. The planimetric assessment and clinical outcomes using Wound Bed Score (WBS) and Bates-Jansen Wound Assessment Tool (BWAT) were assessed before (M0) and after ESWT sessions (M1). Results: There was a significant planimetric enhancement observed after active ESWT reported as a reduction in all metric parameters: wound area from 11.51 to 8.09 cm² (p < 0.001), wound length from 4.97 to 4.41 cm (p < 0.001), and wound width from 3.15 to 2.49 cm (p < 0.0001). Also, there was a significant beneficial clinical improvement observed with a WBS as an increased score from 3.85 to 9.65 points (p < 0.001) and with the BWAT as a decreased score from 45.45 to 30.70 points (p < 0.001). In turn, a regression in the placebo ESWT group was observed in all studied outcomes. Innovation: This study is the first RCT to provide the positive and immediate clinical effects of radial ESWT in promoting the healing of PUs. Conclusion: This preliminary RCT showed that even a single session of ESWT is a promising and clinically effective modality in managing PUs. However, there is still limited data regarding the usefulness of ESWT in PUs, and further studies are in demand.

Objective: To evaluate the effectiveness and adverse events of autologous platelet-rich plasma (PRP) in individuals with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers.

Patients and methods: We searched multiple databases from database inception to June 11, 2020, for randomized controlled trials and observational studies that compared PRP to any other wound care without PRP in adults with lower-extremity diabetic ulcers, lower-extremity venous ulcers, and pressure ulcers.

Results: We included 20 randomized controlled trials and five observational studies. Compared with management without PRP, PRP therapy significantly increased complete wound closure in lower-extremity diabetic ulcers (relative risk, 1.20; 95% CI, 1.09 to 1.32, moderate strength of evidence [SOE]), shortened time to complete wound closure, and reduced wound area and depth (low SOE). No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower-extremity venous ulcers or pressure ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. There was no statistically significant difference in adverse events.

Conclusion: Autologous PRP may increase complete wound closure, shorten healing time, and reduce wound size in individuals with lower-extremity diabetic ulcers. The evidence is insufficient to estimate an effect on wound healing in individuals with lower-extremity venous ulcers or pressure ulcers.

Trial registration: PROSPERO Identifier: CRD42020172817.

Many patients with venous leg ulcers do not reach complete healing with compression treatment alone, which is current standard care. This clinical trial HEAL LL-37 was a phase IIb double-blind, randomized, placebo-controlled study, with the aim to evaluate the efficacy and safety of a new drug LL-37 for topical administration, in combination with compression therapy, in 148 patients suffering from hard-to-heal venous leg ulcers. The study had three arms, consisting of two groups treated with LL-37 at concentrations of 0.5 or 1.6 mg/mL, and a placebo cohort. Patients had a mean age of 67.6 years, a median ulcer duration of 20.3 months, and a mean wound size at the time of randomization of 11.6 cm² . Efficacy analysis performed on the full study population did not identify any significant improvement in healing in patients treated with LL-37 as compared with the placebo. In contrast, a post hoc analysis revealed statistically significant improvement with LL-37 treatment in several interrelated healing parameters in the subgroup of patients with large target wounds (a wound area of at least 10 cm² at randomization), which is a known negative prognostic factor for healing. The study drug was well tolerated and safe in both dose strengths. In summary, this clinical trial did not detect any significant differences in healing of venous lower leg ulcers in the entire study cohort comparing patients treated with LL-37 versus placebo. A subgroup analysis provided an interesting observation that LL-37 could offer a treatment benefit in patients with large ulcers, exigently warranting a further study adequately powered to statistically assess the treatment outcome in this patient group.

Objective: This retrospective trial analyzed the effect of predetermined variables on venous ulcer healing after endovenous ablation of insufficient veins.

Methods: A total of 259 patients presenting 273 venous leg ulcers (VLUs) at Oulu University Hospital vascular outpatient clinic between January 2010 and December 2020 were included in the study. In addition to compression therapy, all patients received endovenous ablation (endothermal ablation and/or foam sclerotherapy) to promote venous healing. The hazard ratio (HR) for an ulcer to heal was analyzed in univariate analysis of predetermined factors, including age, sex, recurrent venous ulcer, presence of great saphenous vein or small saphenous vein reflux, persistent superficial vein reflux after ablation, recanalization in treated segments, ulcer age, body mass index >35 kg/m², history of deep vein thrombosis, history of erysipelas, ability to move, smoking, hypertension, atrial fibrillation, coronary artery disease, diabetes mellitus, and cardiac insufficiency. Logistic regression was used in a multivariate analysis to identify independent risk factors for ulcer healing.

Results: In the univariate analysis, healing was negatively associated with persistent superficial vein reflux after ablation (HR, 0.117; 95% confidence interval [CI], 0.088-0.354), recanalization in treated segments (HR, 0.161; 95% CI, 0.060-0.433), nonambulatory patient (HR, 0.322; 95% CI, 0.130-0.800), history of deep vein thrombosis (HR, 0.518; 95% CI, 0.294-0.910), and presence of small saphenous vein reflux (HR, 0.565; 95% CI, 0.384-0.830). Independent risk factors included persistent superficial vein reflux after ablation (HR, 0.123; 95% CI, 0.0051-0.295). All the patients in the persistent superficial vein reflux group had their VLUs eventually healed after further endovenous treatment.

Conclusions: When treating patients with VLUs, persistent superficial vein reflux after ablation was negatively associated with ulcer healing. After additional endovenous ablative treatment, ulcers with persistent reflux eventually healed.

Various management options were tried for Chronic venous leg ulcers (VLUs) with no satisfactory results. Platelet-rich plasma (PRP) is promising in enhancing chronic wound healing by releasing various growth factors. We evaluated the safety and efficacy of topical platelet gel (PG) vs PRP injection in treatment of venous leg ulcers. 20 patients were treated with topical PG (group I), 20 patients received PRP injection (group II), and 20 patients were treated with saline dressing and compression as controls (group III) weekly for 6 weeks. Ulcer improvement was evaluated by pressure ulcer scale for healing (PUSH). Histopathological evaluation and immunohistochemical staining using anti-CD34 were performed before and after treatment. There was significant improvement in PUSH score in group (I) and (II) compared to group (III; P value: .001). However, there was no statistically significant difference in improvement between group I and II (P value = .83). However, topical PG was more effective in diabetics and PRP was more effective in long standing fibrosed ulcers. Histopathology showed reduction of the inflammatory cells infiltrates and well-formed granulation tissue with no difference in immunostaining. So, both topical PG and PRP injection were effective, low cost, and safe procedures in enhancing healing of chronic VLUs.

Adjuvants to compression are sought for treating venous ulceration. There is animal, observational and trial evidence that suggests statins increase venous ulcer healing. The objective of this study was to conduct secondary analyses investigating the association of statin use with healing in three randomised trials that recruited people with venous ulceration. The difference in healing rates was modest but higher in the statins group. Crude analyses found no significant difference between the groups, but when adjusted for the trial effect and potential confounders (age, diabetes, first ever ulcer, ulcer area and ulcer duration), significantly more participants healed among those taking statins. The analyses were robust to method of analysis (fixed effects or random effects models). A definitive trial is required to evaluate the effect of statins versus placebo on venous ulcer healing, but until then patients needing to take statins seem unlikely to be disadvantaged by this treatment.

Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention-to-treat (ITT) and/or the per-protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias. A previous report from an RCT conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane allograft (EpiFix) as an adjunct to standard comprehensive wound therapy consisting of moist dressings and multi-layer compression in the healing of venous leg ulcers (VLUs) only reported PP study results (n = 109, 52 EpiFix and 57 standard care patients), although there were 128 patients randomised: 64 to the EpiFix group and 64 to the standard care group. Primary study outcome was the incidence of healing at 12 weeks. The purpose of the present study is to report ITT results on all 128 randomised subjects and assess if both ITT and PP data analyses arrive at the same conclusion of the efficacy of EpiFix as a treatment for VLU. Rates of healing for the ITT and PP populations were, respectively, 50% and 60% for those receiving EpiFix and 31% and 35% for those in the standard care cohort. Within both ITT and PP analyses, these differences were statistically significant; P = 0.0473, ITT and P = 0.0128, PP. The Kaplan-Meier plot of time to heal within 12 weeks for the ITT and PP populations demonstrated a superior wound-healing trajectory for EpiFix compared with VLUs treated with standard care alone. These data provide clinicians and health policymakers an additional level of assurance regarding the effectiveness of EpiFix.

Objective: To synthesise the best available evidence regarding the effectiveness of using topical haemoglobin spray to promote healing in hard-to-heal wounds in adults.

Method: The search strategy of this systematic review was designed to retrieve studies published across CINAHL, Medline, Cochrane Central Register of Controlled Trials, Web of Science, Embase, ERIC, Scopus and Mednar, before January 2020, and published in English. All study participants were aged ≥18 years. This review included randomised controlled trials, case-control studies and observational studies. The studies selected for retrieval were assessed by two independent reviewers for methodological validity prior to inclusion using standardised critical appraisal instruments.

Results: The review included 15 studies. Overall effectiveness was demonstrated for wound closure rates, reductions in wound size, severity of wound pain and patient satisfaction with using a topical haemoglobin spray. The meta-analysis revealed a statistically significant effect of a topical haemoglobin spray in reducing the size of venous leg ulcers (VLU, effect size=0.02; 95% confidence interval: 0.00-0.09; p<0.00001) in adult patients. However, evidence of the effectiveness of using a topical haemoglobin spray in different wound types among adult patients was limited and not high-level, which precludes any strong conclusions.

Conclusion: The review provides an evidence-based guide to future priorities for clinical practice. In particular, a topical haemoglobin spray was shown to have a positive impact in reducing VLU size and promoting wound healing.

Wound healing has been greatly challenging in different acute and chronic skin injuries. Among them, nonrevascularizable critical limb ischemic ulcers, venous leg ulcers, and diabetic lower limb or extremity ulcers are well-known refractory skin injuries that are difficult to treat. Partly differentiated, progenitor cell-based graft transplantation or direct injection of autologous stem cells might promote the wound healing process. Studies aiming to comprehensively analyze the effects of cell therapy on skin wound healing could provide clinical evidence for skin injury treatment. Different databases were searched for full-text publications on the comparison between cell therapy and regular therapy. Heterogeneity was detected by the I² method, and a fixed effect model was applied for data pooling if heterogeneity was absent. Publication bias was analyzed using a funnel plot, and 10 studies were finally included in this study. After a long-term follow-up, fewer patients underwent major amputation in the cell therapy group, compared with the standard therapy group, and those in the cell therapy group were characterized by a smaller ulcer area. Moreover, there was a significant difference in the wound healing rate between the intervention and control groups. However, pain caused by skin wounds was hardly mitigated by cell therapy in patients with critical limb ischemia. In this study, cell therapy proved effective in decreasing the size of ulcers and improving the wound closure rate. Additionally, the major amputation rate was decreased in the cell therapy group. However, the symptoms of pain were hardly alleviated by cell therapy in patients with cutaneous ulcers caused by peripheral artery disease-related critical limb ischemia.

A multicenter, phase 4, randomized, comparative-efficacy study in subjects with lower extremity wounds was carried out to compare wound closure rates, for a single-use negative pressure wound therapy (s-NPWT) versus traditional NPWT (t-NPWT) systems over a 12-week treatment period. From the initial population of patients with diabetic foot ulcers (DFU) and venous leg ulcers (VLU), we analyzed a subgroup of patients with diabetes mellitus and leg and foot ulcers (either DFUs or VLUs in diabetics), termed, the diabetic lower extremity ulcers (DLEU). In the DLEU group, there were 95 patients in intention-to-treat (ITT) and 61 patients in per protocol (PP) populations, respectively. We found a significant difference in favor of s-NPWT over t-NPWT in the confirmed wound closures at 12 weeks both in ITT (p < 0.001) and PP populations (p = 0.017). Significantly higher wound closure rates in s-NPWT group suggest that s-NPWT should be preferred NPWT option for DLEU.

Objective: Debridement, the removal of nonviable tissue, forms the foundation of wound care practice. Clinicians have a variety of debridement methods at their disposal: sharp, biologic, enzymatic, autolytic and mechanical. The choice of debridement technique depends on the patient care setting, ulcer type and the clinician's experience, training, comfort level and licensure. This prospective study evaluated a novel debridement instrument, EZ-Debride (MDM Ventures, US). Cutting flutes on the head of the tool permit uniform removal of dead tissue while lessening the risk of deeper injury. It may also minimise pain during the debridement procedure.

Method: Subjects with hard-to-heal wounds, drawn from a single wound care centre, participated in this institutional review board-approved prospective clinical study. Pain was measured before, during and after debridement using a numerical scale. Assessment of bacterial burden using fluorescence imaging (MolecuLight, Canada) was performed before and after debridement.

Results: Enrolment of 10 male and 12 female subjects, with a total of 28 wounds, was carried out over a two-month period by two investigators at a single institution. The average age of subjects was 64 years (range: 22-95 years). The average wound duration was 29 weeks (range: 6-142 weeks). Wound types included diabetic foot, venous leg and pressure ulcers, post-surgical and traumatic wounds. The average pain score at the time of enrolment was 3.9. Subjects reported an average increase in pain with debridement of 0.6 points (range: 0-8). Fluorescence imaging demonstrated a reduction in bacterial load in 69% of cases, with complete resolution in 19% of wounds. Haemostasis was achieved with direct pressure in all cases and the only adverse event was a wound infection that occurred four days after debridement.

Conclusion: The results suggest that this novel debridement tool can safely remove nonviable tissue with minimal discomfort and reduce bacterial burden similar to results achieved by sharp debridement.