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

Recruiting now · Phase 4

Conditions studied: Foot Ulcers, Diabetic

In brief

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.

Key facts

Study ID

NCT06952998

Run by

Biotechnology Institute IMASD

People needed

38

Starts

2025-11-01

Expected to finish

2027-05-30

Last updated by the study team

2025-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Peripheral Arterial Disease (PAD)
• Meet at least 2 of the following crieria:
• Absence of peripheral pulses at any level on physical examination of lower extremities
• Ankle pressure of 50-90 mmHg
• Finger pressure 30-70 mmHg
• Ankle-branchial index (ABI) 0.5-0.9
• Finger-arm index (FIBI) 0.3-0.7
• Transcutaneous oxygen pressure (TcPO2) 30-59 mmHg
• Degree of infection of the lesion on IDSA/IWGDF scale not greater than 1
• Availability of observation during the study period
• Properly completed patient informed consent

You may not qualify if…

• 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
• History of cancerous or precancerous lesions in the area of intervention
• On active treatment with other local treatment at the site of treatment
• On active treatment with immunosuppressants and/or other drugs contraindicating blood collection
• History of allergy to blood derivatives
• Previous diagnosis of coagulopathies
• Regular and continuous treatment (≥ 3 months) with NSAIDs (with the exception of the use of acetylsalicilic acid)
• Pregnancy or women of chilbearig age not taking effective contraceptive measures. These methods are, according to recommendations of the Clinical Trial Facilitation Group (CTFG) Contraception Working Group (CTFG) (V1.1), the following Hormonal contraception associated with ovulation inhibition, intrauterine decide (IUD), intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy partner, sexual abstinence
• Breastfeeding women
• Treatment with monoclonal antibodies
• Any inabilities to participate in the study

Where it is running

• Hospital Universitario de Basurto. — Bilbao, Bizkaia, Spain (enrolling)

Full record on ClinicalTrials.gov

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