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

Phase

Condition

Circulation Disorders

Peripheral Arterial Occlusive Disease

Claudication

Treatment

Topical application of Plasma Rich in Growth Factors (PRGF)

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

Clinical Study ID

NCT06952998

BTIIMD-01-EC-23-PIEDIABETICO

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 lowerextremities
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

Exclusion

Exclusion Criteria:

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 contraindicatingblood collection
History of allergy to blood derivatives
Previous diagnosis of coagulopathies
Regular and continuous treatment (≥ 3 months) with NSAIDs (with the exception of theuse of acetylsalicilic acid)
Pregnancy or women of chilbearig age not taking effective contraceptive measures.These methods are, according to recommendations of the Clinical Trial FacilitationGroup (CTFG) Contraception Working Group (CTFG) (V1.1), the following Hormonalcontraception 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

Study Design