Using Plasma Rich in Growth Factors to Heal Foot Ulcers in Diabetic Patients with Peripheral Arterial Disease
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
This study is testing whether a special treatment using plasma rich in growth factors can help heal foot ulcers in diabetic patients with poor blood flow better than standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotechnology Institute IMASD Industry-sponsored |
| Locations | 1 site (Bilbao, Bizkaia) |
| Trial ID | NCT06952998 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Plasma Rich in Growth Factors (PRGF) compared to conventional treatment for healing foot ulcers in diabetic patients suffering from peripheral arterial disease. The study involves a randomized approach where participants receive either PRGF or standard care over a six-month period. The primary goal is to determine how well PRGF promotes healing of ulcers that are 1 to 25 cm² in size. Eligible participants must be at least 18 years old and meet specific criteria related to their diabetes and arterial health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes who have foot ulcers and peripheral arterial disease.
Not a fit: Patients with ulcers graded 3 or higher, those with poor metabolic control, or active systemic infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for diabetic patients with foot ulcers, potentially reducing complications and improving quality of life.
How similar studies have performed: While the use of growth factors in wound healing has been explored, this specific application in diabetic foot ulcers with peripheral arterial disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bilbao, Bizkaia
- Hospital Universitario de Basurto. — Bilbao, Bizkaia, Spain (Recruiting)
Study contacts
- Study coordinator: Aitana Sainz
- Email: aitana.sainz@bti-implant.es
- Phone: +34 945 160 653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.