Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study
Authors Yakoot M, Abdelatif M, Helmy S
Received 31 March 2019
Accepted for publication 30 July 2019
Published 2 September 2019 Volume 2019:12 Pages 1659—1665
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Nicola Ludin
Peer reviewer comments 3
Editor who approved publication: Dr Muthuswamy Balasubramanyam
Mostafa Yakoot,1 Mahmoud Abdelatif,2 Sherine Helmy3
1Internal Medicine Department, Green Clinic and Research Center, Alexandria, Egypt; 2General Surgery Department, Alexandria Health Insurance Hospitals, Alexandria, Egypt; 3Research and Innovations, Pharco Corporate, Alexandria, Egypt
Correspondence: Mostafa Yakoot
Internal Medicine Department, Green Clinic and Research Center, Alexandria 21121, Egypt
Tel +20 3 391 3725
Background: Diabetic foot ulcer (DFU) is the main risk factor for nontraumatic lower-limb amputation. We hypothesized that by reversing the offending local tissue factors resulting from the low tissue supply of oxygen, inefficient fuel metabolism and acidosis, we can eradicate the infection and help to promote healing. This might be enhanced with the help of an innovated local preparation (PEDYPHAR®,) through its enriched alkaline ointment base and the regenerating growth factors of Royal Jelly (RJ) plus the antimicrobial, immune-modulatory nutritional and other biochemical properties of RJ and Panthenol. We conducted this study to test the safety and efficacy of PEDYPHAR ointment as an adjuvant in limb salvage management for patients with limb-threatening diabetic foot wounds.
Methods: A prospective, randomized, controlled open-label study design with a mean follow-up period of 12 weeks. One hundred and nineteen eligible patients with diabetic foot wounds presenting to 3 outpatient clinics in Egypt were randomized to be treated with the local application of either PEDYPHAR or Panthenol ointment under dressing after conservative debridement of necrotic tissue and irrigation with warm normal saline.
Results: At the end of the 12-week follow-up period, PEDYPHAR showed a higher rate of complete healing of limb-threatening wounds in the intent-to-treat population, 11 of 34 (32.4%) in PEDYPHAR-treated group versus 3/25 (12%) in the Panthenol-treated (control) group (p=0.034* [*indicates it is statistically significant]).
Conclusion: We can conclude that PEDYPHAR could be an effective and safe conservative local adjuvant treatment for cases of diabetic foot infection.
Registration number in ClinicalTrials.gov: NCT01531517.
Keywords: diabetic foot ulcers, limb threatening, local treatment, Royal Jelly, Panthenol
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