Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06952998

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

Led by Biotechnology Institute IMASD · Updated on 2025-09-11

38

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

Sponsors

B

Biotechnology Institute IMASD

Lead Sponsor

H

Hospital de Basurto

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 criteria:
  • 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
Not Eligible

You will not qualify if you...

  • 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 childbearing age not taking effective contraceptive measures
  • Breastfeeding women
  • Treatment with monoclonal antibodies
  • Any inabilities to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario de Basurto.

Bilbao, Bizkaia, Spain, 48013

Actively Recruiting

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Research Team

A

Aitana Sainz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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