NCT06952998 Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease
| NCT ID | NCT06952998 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Biotechnology Institute IMASD |
| Condition | Foot Ulcers, Diabetic |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 38 participants in total. It began in 2025-11-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06952998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Foot Ulcers, Diabetic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06952998 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06952998 currently recruiting?
Yes, NCT06952998 is actively recruiting participants. Contact the research team at aitana.sainz@bti-implant.es for enrollment information.
Where is the NCT06952998 trial being conducted?
This trial is being conducted at Bilbao, Spain.
Who is sponsoring the NCT06952998 clinical trial?
NCT06952998 is sponsored by Biotechnology Institute IMASD. The trial plans to enroll 38 participants.