Clinical trial NCT06952998: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Foot Ulcers, Diabetic
Lead sponsor: Biotechnology Institute IMASD
Sponsor class: INDUSTRY
Collaborators: name: Hospital de Basurto
First posted: 2025-05-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Assessment of ulcer healing evaluated with the RESVECH 2.0 index at six months
timeFrame: 6 months follow up
Secondary outcomes:
measure: Change in ulcer size at three and six months (percent) (area and depth)
timeFrame: 3 and 6 months follow up
measure: Frequency of ulcers with complete closure at three and six months (percent)
timeFrame: 3 and 6 months follow up
measure: Assessment of ulcer healing assessed with the RESVECH 2.0 index at baseline and at three months
timeFrame: Baseline and three months follow up
measure: Assessment of amputation risk as measured by the WIfI scale at baseline, 3 and 6 months
timeFrame: Baseline, 3 and 6 months follow up
measure: Assessment of pain and quality of life at baseline, three and six months using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
timeFrame: Baseline, 3 and 6 months follow up
measure: Evaluation of wound closure time
timeFrame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
measure: Safety endpoint. Incidence and type of adverse events
timeFrame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
measure: Safety endpoint. Presence of infetion at three and six months assessed with the IWGDF/IDSA classification
timeFrame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
measure: Safety endpoint. Frequancy and type of deficiencies of the medical devices used for PRGF preparation.
timeFrame: Throughout the study duration, assessed at each follow-up visit (up to 6 months post-enrollment)
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto.
state: Bizkaia
Study officials:
References: