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

Biotechnology Institute IMASD

Status and phase: Enrolling; Phase 4

Conditions: Foot Ulcers, Diabetic

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06952998

BTIIMD-01-EC-23-PIEDIABETICO

Details and patient eligibility

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Topical application of Plasma Rich in Growth Factors (PRGF)

Experimental group

Description:

The Principal Investigator, or duly delegated qualified personnel, is responsible for the preparation using the KMU10-TPC Kit (BTI Biotechnology Institute, S.L.).

Treatment:

Drug: Topical application of Plasma Rich in Growth Factors (PRGF)

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

Active Comparator group

Description:

Manufacturer: N/A

Treatment:

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