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Tests treatment safety and results for Foot Ulcers, Diabetic
Official title Efficacy of Plasma Rich in Growth Factors (PRGF) in the Treatment of Foot Ulcers in Diabetic Patients With Peripheral Arterial Disease
ClinicalTrials.gov ID: NCT06952998
What this study is testing
What is Topical application of Plasma Rich in Growth Factors (PRGF)?
Topical application of Plasma Rich in Growth Factors (PRGF) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for foot ulcers, diabetic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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)...
- Breastfeeding women
- Treatment with monoclonal antibodies
- Any inabilities to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Bilbao, Bizkaia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bilbao, Bizkaia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.