Hope for Healing Difficult-to-treat Chronic
Diabetic Foot Ulcers
Italian researchers report that polydeoxyribonucleotide (PDRN), an adenosine receptor A2A agonist, shows some efficacy in healing chronic diabetic foot ulcers....
The aim of the randomized, double-blind, placebo-controlled trial which involved two medical centers in Italy was to evaluate the effect of PDRN on chronic ulcer healing in patients with diabetes.
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 3 days a week for 8 weeks by intramuscular and perilesional route. The primary outcome was complete ulcer healing. Secondary outcomes were the days needed to complete wound closure and the reepithelialization of wound surface (as percentage of the original area).
After 8 weeks, 91 placebo and 101 PDRN subjects completed the study. Complete healing was achieved in 18.9% [95% confidence interval (CI) 11.4–26.3] of placebo and in 37.3% (95% CI 28.2–46.3) of PDRN-treated patients (P = .0027). After 8 weeks, PDRN increased the closure of foot ulcers in diabetic subjects (hazard ratio 2.20; 95% CI 1.29–3.75; P = .004). The median time to complete wound healing was 49 days for placebo (range 28–56 d) and 30 days for PDRN-treated subjects (range 14–56 d; P = .0027). The median epithelialized area of the ulcers (expressed as percentage) was 49.3% in the placebo and 82.2% in the PDRN group (P < .001).
The researchers concluded that PDRN facilitates the healing of Wagner 1 or 2 diabetic foot ulcers.
Lead author Francesco Squadrito, MD, of the University of Messina, Italy, said that the next step will be a phase 4 study involving more centers in Italy and possibly the European registration of the product to make PDRN in diabetic foot ulcer more widely available. PDRN is the active fraction of a preparation used in Italy as a tissue repair and stimulating agent and is extracted from the sperm of trout bred for feeding purposes, he and his colleagues explain. The manufacturer (Placentex, Mastelli, Sanremo, Italy) has filed a request for claims on ulcer healing, Dr. Squadrito added.
The researchers are also planning another randomized controlled trial involving patients with ulcers of grade 3 to 5. This study will compare the efficacy and safety of PDRN with hyperbaric oxygen therapy.
J Clin Endocrinol Metab. Published online January 31, 2014.