NCT06952998 - Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease | Crick

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

38

Conditions

Foot Ulcers, Diabetic

Interventions

Topical application of Plasma Rich in Growth Factors (PRGF)DRUG

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).

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

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario de Basurto.

Bilbao, Bizkaia, Spain

RECRUITING

Outcomes

Primary Outcomes

Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months

RESVECH 2.0 (Expected Results of the Assessment and Evolution of Chronic Wound Healing Index). Composed of 6 variables whose psychometric properties are detailed as follows: reliability through internal consistency with a Cronbach's α of 0.63 and a Cronbach's α based on typed items of 0.72 (indicating greater consistency the closer α is to 1); with a content validity index for the total of the scale higher than 0.9, being called RESVECH2.0. These 6 final items that it assesses are: 1. Injury dimensions 2. Depth/tissues affected 3. Edges 4. Type of tissue in the wound bed 5. Exudate 6. Infection-inflammation (signs-biofilm) Thus, each of them receives a score, considering a total value of 0 for the healed ulcer, and reaching a maximum of 35 points as the worst possible wound as a result of the evaluation.

Time frame: 6 months follow up

Secondary Outcomes

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

RESVECH 2.0 (Expected Results of the Assessment and Evolution of Chronic Wound Healing Index). Composed of 6 variables whose psychometric properties are detailed as follows: reliability through internal consistency with a Cronbach's α of 0.63 and a Cronbach's α based on typed items of 0.72 (indicating greater consistency the closer α is to 1); with a content validity index for the total of the scale higher than 0.9, being called RESVECH2.0. These 6 final items that it assesses are: 1. Injury dimensions 2. Depth/tissues affected 3. Edges 4. Type of tissue in the wound bed 5. Exudate 6. Infection-inflammation (signs-biofilm) Thus, each of them receives a score, considering a total value of 0 for the healed ulcer, and reaching a maximum of 35 points as the worst possible wound as a result of the evaluation.

Central Contacts

Aitana Sainz

CONTACT

+34 945 160 653 aitana.sainz@bti-implant.es