Objective: To evaluate the healing rate of venous leg ulcers treated with Promogran.
Method: Patients with stagnating venous leg ulcers were recruited. Target wounds were > or = 2 cm but < or = 10 cm in any one dimension. Subjects were randomly allocated to receive either Promogran or a non-adherent dressing (Adaptic) with a secondary dressing of gauze followed by short-stress compression (Biflex). Weekly wound assessments occurred over 12 weeks and dressings were changed twice weekly by the investigator and/or nurse team. Planimetry tracings and photographs were blindly reviewed and assessed by two independent investigators. An intent-to-treat analysis was performed.
Results: Seventy-three patients were included. Thirty-seven were randomly allocated Promogran and 36 Adaptic. Twenty-nine patients completed the 12-week follow-up visit, 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing. Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing (22.2% versus 5.4%; p = 0.035). Eleven venous leg ulcers healed in the control group (31%) and 15 in the Promogran group (41%) (p = 0.373). Overall, 15 venous leg ulcers healed or improved in the control group (42%) and 23 in the Promogran group (62%) (p = 0.079). Surface area decreased, on average, by 36.5 +/- 11.4% (median decrease: 44.6%) in the Adaptic group and by 54.4 +/- 10.9% (median decrease: 82.4%) in the Promogran group (p < 0.001). A < or = 20% surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group (42% versus 19%; p = 0.034). No severe local adverse events were noted in either group, although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group. Dressing acceptability was good or excellent in more than 60% of subjects in both groups.
Conclusion: The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current standard of care.