Platelet concentrate for Diabetic foot ulcer | Peripheral arterial disease | Diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Patients aged at least 18 years\n- Diagnosis of type 1 or 2 diabetes\n- Presence of one or more ulcers below the malleoli\n- Ulcer size ranging from 1 to 25 cm2\n- Absence of active infection as assessed using the fourth criterion of the SINBAD scale\n- Availability of observation during the study period\n- Properly completed patient informed consent"}

Exclusion criteria

• {"criterion_text":"- Positive markers for HCV, AfHBs, HIV-I/II or TP\n- Diabetes mellitus with poor metabolic control (evidence of glycosylated hemoglobin > 9%)\n- Active systemic infection\n- History of cancerous or precancerous lesions in the area of intervention\n- On active treatment with other local treatments at the site of treatment\n- On active treatment with immunosuppressants and/or other drugs contraindicating blood collection\n- History of allergy to blood derivatives\n- Previous diagnosis of coagulopathies\n- Regular and continuous treatment (≥ 3 months) with NSAIDs (with the exception of the use of acetylsalicylic acid)\n- Pregnancy or women of childbearing age not taking effective contraceptive measures. These methods are, according to the recommendations of the Clinical Trial Facilitation Group (CTFG) Contraception Working Group (CTFG) (V1.1), the following: Hormonal contraception associated with ovulation inhibition, intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal ligation, vasectomy partner, sexual abstinence\n- Breastfeeding women\n- Treatment with monoclonal antibodies\n- Any inabilities to participate in the study"}

Primary endpoints

• {"endpoint_text":"- Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months","definition_or_measurement_approach":"Ulcer healing assessed using the RESVECH 2.0 index at six months"}

Secondary endpoints

• {"endpoint_text":"- Age\n- Sex\n- Toxic habits (tobacco, alcohol)\n- Body mass index\n- Time of evolution\n- Etiology (Type of diabetes)\n- Ulcer dimensions (area and depth)\n- Previous treatments\n- Change in ulcer size at three and six months (%) (area and depth)\n- Frequency of ulcers with complete closure at three and six months (%)\n- Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months\n- Assessment of the severity of the ulcer as measured by the SINBAD scale at baseline, 3 and 6 months.\n-Assessment of pain and quality of life at baseline, three and six months using the EQ-5D-5L scale\n- Cost of wound closure\n- Incidence and type of adverse events\n- Presence of infection according to SINBAD criterion 4 at baseline, three and six months\n- Frequency and type of deficiencies of the medical devices used for PRGF preparation\n- Biomarkers involved in tissue damage repair","definition_or_measurement_approach":"Age, Sex, Toxic habits and BMI: demographic/clinical descriptors collected at baseline.\nTime of evolution, Etiology (Type of diabetes), Ulcer dimensions (area and depth), Previous treatments: baseline clinical descriptors and history.\nChange in ulcer size at 3 and 6 months: percent change in area and depth measured at 3 and 6 months.\nFrequency of ulcers with complete closure at 3 and 6 months: proportion of ulcers fully closed at those time points.\nAssessment of ulcer healing at baseline and 3 months: RESVECH 2.0 index applied at baseline and 3 months.\nSeverity assessment: SINBAD scale at baseline, 3 and 6 months.\nPain and quality of life: EQ-5D-5L at baseline, 3 and 6 months.\nCost of wound closure: health-economic cost assessment of closure.\nAdverse events: incidence and type collected per safety reporting.\nPresence of infection: evaluated according to SINBAD criterion 4 at baseline, 3 and 6 months.\nDevice deficiencies: frequency/type of deficiencies of medical devices used for PRGF preparation.\nBiomarkers: assessment of biomarkers involved in tissue damage repair (unspecified biomarkers)."}

Spain

Earliest CTIS Part Ii Submission Date

05-04-2024

Latest Decision Or Authorization Date

11-09-2025

Processing Time Days

524

Number Of Sites

1

Number Of Participants

38

Primary sponsor

Full Name

Biotechnology Institue I Mas D S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain