PDRN (Polydeoxyribonucleotide) for diabetic foot ulcers

NewsBot · Feb 4, 2014

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THE EFFECT OF PDRN, AN ADENOSINE RECEPTOR A2A AGONIST, ON THE HEALING OF CHRONIC DIABETIC FOOT ULCERS: RESULTS OF A CLINICAL TRIAL
Francesco Squadrito, et al
The Journal of Clinical Endocrinology & Metabolism; Ahead of Print

Context:
Foot ulcer is the principal cause of hospitalization for patients with diabetes. Polydeoxyribonucleotide (PDRN), an adenosine A2A receptor agonist, improves wound healing in diabetic mice.
Objective:
Aim of this study was to evaluate the effect of PDRN on chronic ulcer healing in patients with diabetes.
Design and Setting:
This randomized, double-blind, placebo-controlled trial, involved 2 medical centers in Italy.
Intervention:
Patients with diabetes showing hard-to-heal ulcers (Wagner grade 1 or 2), were randomly assigned to receive placebo (n=106) or PDRN (n=110). The treatments (PDRN and placebo) were performed three days a week for 8 weeks, by intramuscular and peri-lesional route.
Main outcome measures:
The primary outcome was complete ulcer healing. Secondary outcomes were the days needed to complete wound closure and the re-epithelialization of wound surface (as % of the original area).
Results:
After 8 weeks, 91 placebo and 101 PDRN subjects completed the study. Complete healing was achieved in 18.9% (95%CI 11.4–26.3) of placebo and in 37.3% (95%CI 28.2–46.3) of PDRN treated patient (p=0.0027). After 8 weeks, PDRN increases the closure of foot ulcers in diabetic subjects (HR= 2.20; 95% CI 1.29–3.75; p=0.004). The median time to complete wound healing, was 49 days for placebo (range 28–56) and 30 days for PDRN treated subjects (range 14–56; P=0.0027). The median epithelialized area of the ulcers (expressed as %), was 49.3% in the placebo and 82.2% in the PDRN group (P<0.001).
Conclusions:
PDRN facilitates healing of Wagner 1 or 2 diabetic foot ulcers.
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