Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotechnology Institute IMASD

About this trial

This study is a randomized clinical trial that compares the effectiveness of Plasma Rich in Growth Factors (PRGF) with conventional treatment for healing foot ulcers in diabetic patients who also have peripheral arterial disease. The goal is to assess how well PRGF promotes healing over a six-month period.

Eligibility criteria

Qualifiers

Patients aged at least 18 years

Diagnosis of type 1 or 2 diabetes

Presence of one or more ulcers below the malleoli

Ulcer size ranging from 1 to 25 cm2

Disqualifiers

Ulcers grade 3 or higher

Positive markers for HCV, AfHBs, HIV-I/II or TP

Diabetes mellitus with poor metabolic control (evidence of glycosylated hemoglobin >9%)

Active systemic infection

Trial design

Treatments tested in this trial

  • Topical application of Plasma Rich in Growth Factors (PRGF)
  • Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Biotechnology Institute IMASD

Lead sponsor

Hospital de Basurto

Collaborator