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

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

Overview

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.

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 det

Primary outcome measures

• Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months [Time frame: 6 months follow up]

Secondary outcome measures (9)

• Change in ulcer size at three and six months (percent) (area and depth) [Time frame: 3 and 6 months follow up]
• Frequency of ulcers with complete closure at three and six months (percent) [Time frame: 3 and 6 months follow up]
• Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months [Time frame: Baseline and three months follow up]
• Assessment of amputation risk as measured by the WIfI scale at baseline, 3 and 6 months [Time frame: Baseline, 3 and 6 months follow up]
• Assessment of pain and quality of life at baseline, three and six months using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) [Time frame: Baseline, 3 and 6 months follow up]
• Evaluation of wound closure time [Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)]
• Safety endpoint. Incidence and type of adverse events [Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)]
• Safety endpoint. Presence of infetion at three and six months assessed with the IWGDF/IDSA classification [Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)]
• Safety endpoint. Frequancy and type of deficiencies of the medical devices used for PRGF preparation. [Time frame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universitario de Basurto. — Bilbao

Identifiers

NCT: NCT06952998 · BTIIMD-01-EC-23-PIEDIABETICO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗