Efficacy of a new local limb salvage treatment for limb-threatening diabetic foot wounds - a randomized controlled study

Abstract

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.

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Keywords:

• diabetic foot ulcers
• limb threatening
• local treatment
• Royal Jelly
• Panthenol

Acknowledgments

The product PEDYPHAR used in this study has been manufactured by Pharco. We acknowledge the help of coworkers from Alexandria University in collecting the data.

Data sharing statement

Authors are willing to share some of the unidentified photos of some patients’ lesions before and after treatment. This could be uploaded to the journal site.

Author contributions

Yakoot M and Abdelatif M conceived the idea and designed the study. Helmy S formulated the study medication. Yakoot M and Abdelatif M from Alexandria Faculty of Medicine collected the clinical data. Yakoot M prepared the first draft of the paper. All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

MY had conducted clinical studies for Pharco. SH is employeed by and holds stocks in Pharco. The authors report no other conflicts of interest in this work.