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RECRUITING
NCT06952998
PHASE4

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

Sponsor: Biotechnology Institute IMASD

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Clinical Trial, Controlled With Conventional Treatment to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-11-01

Completion Date

2027-05-30

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

DRUG

Topical application of Plasma Rich in Growth Factors (PRGF)

Topical application of PRGF will be maintained each time the patient undergoes the conventional treatment. The frequency of conventional treatment will be determined by the health specialist according to the evolution of the ulcer. The treatment will be maintained until complete wound closure or until the end of the follow-up period (6 months).

PROCEDURE

Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic).

Conventional treatment (conventional treatment with adequate offloading and metabolic control, +/- antibiotic). The "TIME" dynamic wound closure strategy will be followed, which summarizes the four key points to stimulate the natural healing process: control of non-viable tissue, control of inflammation and infection, control of exudate and stimulation of the edges. After healing, chlorhexidine spray will be applied topically to these patients. The frequency of conventional treatment will be determined by the health specialist according to the evolution of the ulcer. Treatment will be maintained until complete wound closure or until the end of the follow-up period (6 months).

Locations (1)

Hospital Universitario de Basurto.

Bilbao, Bizkaia, Spain