Controlled and randomized clinical trial of the use of plasma rich in growth factors (PRGF) in the treatment of foot ulcers in diabetic patients.
- Conditions
- Foot ulcers in diabetic patients with peripheral arterial diseaseTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-504275-24-01
- Lead Sponsor
- Biotechnology Institue I Mas D S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
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 criteria: ? 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-brachial 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
- 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 treatments 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 acetylsalicylic acid) - Pregnancy or women of childbearing age not taking effective contraceptive measures as outlined in CTFG Recommendations related to contraception and pregnancy testing in clinical trials V 1. - Breastfeeding women - Treatment with monoclonal antibodies - Any inabilities to participate in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method