Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers

University of Messina215 enrolled

Overview

The main objective of the study is to evaluate the efficacy of the polydeoxyribonucleotide in improving the healing of diabetic foot ulcers.

This trial will involve diabetic patients with foot ulcers who meet the inclusion/exclusion criteria. At least 200 patients aged 45-80yrs will be enrolled in the study and randomly allocated to receive the active drug or the placebo in indistinguishable formulations. After 2 months closure rate of the ulcer will be evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

215

Conditions

Diabetic Ulcer Foot Ulcer Unhealed

Interventions

PolydeoxyribonucleotideDRUG

3 times a week perilesional or intramuscular injections

0.9% NaClOTHER

same as PDRN

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 45-80yrs * Minimum schooling 5yrs * Type I or II diabetes since at least 5yrs with a stable metabolic control * Foot ulcer since minimum 2 weeks * Ulcer \>1cm and \<16cm at day 0 * Ulcer grade 1 or 2 wagner scale * Wound free of necrotic debris * TcPO2 \>29mmHg * Not pregnant or lactant Exclusion Criteria: * Non-consenting patient * History of alcohol or drug abuse * Gangrene on any part of the affected foot * Ongoing untreated infections * Ulcer over a charcot deformity * Use of a systemic cicatrizant drug in the past 10 days * Malnutrition * Neurological or psychiatric pathologies * Liver or kidney insufficiency * Corticosteroid or immunosuppressive or cytotoxic therapy * Other severe pathologies * Proven hypersensitivity to the drug or to any related component

Locations (1)

University of Messina

Messina, Italy

Outcomes

Primary Outcomes

reduction of ulcer rate

Time frame: 3 months

Secondary Outcomes

safety and tolerability of the compound

Time frame: 6 months

Data from ClinicalTrials.gov

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