Objective: To study the effectiveness and safety of PEDYPHAR ointment (a new ointment prepared from natural royal jelly and panthenol in an ointment base) in the treatment of patients with limb-threatening diabetic foot infections.
Method: Sixty patients presenting with limb-threatening diabetic foot infection were categorised into three groups, based on the severity of the lesions. Group I: full-thickness skin ulcer (Wagner grades 1 and 2); group 2: deep tissue infection and suspected osteomyelitis (grade 3); group 3: gangrenous lesions (grades 4 and 5). They were treated with PEDYPHAR ointment after irrigation and cleansing with normal saline, and surgical debridement if required. The lesions were covered with dressings and patients were followed up for six months or until full healing occurred. No other specific treatment was given apart from insulin treatment to control the diabetes. The primary endpoint was the clinical response at weeks 3, 9 and 24 from the start of treatment.
Results: Ninety-six per cent of the patients in groups 1 and 2 responded well, with a complete cure, defined as'complete closure of the ulcer without signs of underlying bone infection' by the end of week 9 and for the duration of the six-month follow-up period. All of the ulcers in group 1 healed, as did 92% of those in group 2. All patients in group 3 healed following surgical excision, debridement of necrotic tissue and conservative treatment with PEDYPHAR ointment.
Conclusion: We can conclude from our pilot study that PEDYPHAR ointment may be a promising, safe conservative local treatment. However, further double-blind randomised controlled studies are needed to confirm this.