Study on the Use of Plasma Rich in Growth Factors for Treating Foot Ulcers in Diabetic Patients with Peripheral Arterial Disease

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What is this study about?

This clinical trial is focused on studying the treatment of foot ulcers in patients with diabetes who also have peripheral arterial disease. The treatment being tested is called Plasma Rich in Growth Factors (PRGF), which is a gel made from a concentrate of platelets, a component of blood that helps with healing. The purpose of the study is to evaluate how effective this treatment is in helping foot ulcers heal over a period of six months.

Participants in the study will receive either the PRGF treatment or a conventional treatment, and the progress of their foot ulcers will be monitored and assessed. The study will last for six months, during which the healing of the ulcers will be evaluated using a specific index designed to measure healing progress. The study aims to see if the PRGF treatment can improve the healing process compared to the usual treatments available.

Throughout the study, various aspects such as the size of the ulcers, the risk of amputation, and the quality of life of the participants will be assessed. The study will also monitor any side effects or adverse events that may occur during the treatment period. The ultimate goal is to determine if PRGF can be a more effective option for treating foot ulcers in diabetic patients with peripheral arterial disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diabetes diagnosis, and presence of foot ulcers.

Informed consent is required to participate in the study.

2 initial assessment

An initial assessment of the foot ulcer is conducted using the RESVECH 2.0 index.

Baseline measurements include ulcer size, depth, and other health indicators.

3 treatment administration

The treatment involves the application of plasma rich in growth factors (PRGF) in the form of a gel.

The gel is applied topically to the ulcer site.

4 follow-up assessments

Follow-up assessments occur at three and six months to evaluate ulcer healing progress.

The RESVECH 2.0 index is used to measure changes in ulcer size and healing.

5 evaluation of outcomes

Primary outcomes include the assessment of ulcer healing at six months.

Secondary outcomes involve changes in ulcer size, frequency of complete closure, and quality of life assessments.

6 completion of study

The study concludes with a final evaluation of the ulcer and overall health status.

Data collected throughout the study is analyzed to determine the efficacy of the treatment.

Who Can Join the Study?

Patients must be at least 18 years old.
Patients must have a diagnosis of type 1 or type 2 diabetes.
Patients must have one or more ulcers located below the ankle bones, known as the malleoli.
The size of the ulcer must be between 1 and 25 square centimeters.
Patients must have Peripheral Arterial Disease (PAD), which means there is reduced blood flow to the legs and feet.
Patients must meet at least two of the following criteria related to blood flow and pressure in the legs and feet:
- Absence of pulses in the lower legs when checked by a doctor.
- Ankle pressure between 50 and 90 mmHg, which is a measure of blood pressure at the ankle.
- Finger pressure between 30 and 70 mmHg, which is a measure of blood pressure in the fingers.
- Ankle-brachial index (ABI) between 0.5 and 0.9, which compares blood pressure in the ankle to the arm.
- Finger-arm index (FIBI) between 0.3 and 0.7, which compares blood pressure in the finger to the arm.
- Transcutaneous oxygen pressure (TcPO2) between 30 and 59 mmHg, which measures oxygen levels in the skin.
The infection level of the ulcer must not be greater than 1 on the IDSA/IWGDF scale, which is a way to measure how severe the infection is.
Patients must be available for observation during the study period.
Patients must have properly completed the informed consent form, which means they agree to participate in the study after understanding what it involves.

Who Cannot Join the Study?

Patients who do not have foot ulcers caused by diabetes and peripheral arterial disease. Peripheral arterial disease is a condition where blood vessels outside the heart and brain become narrow, reducing blood flow to the limbs.
Patients who are not within the specified age range for the study.
Patients who belong to a clinical trial group that is not included in this study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Basurto	Bilbao	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Platelet Concentrate

Plasma Rich in Growth Factors (PRGF) is a therapy being tested in this clinical trial. It involves using a special preparation of plasma, which is a component of blood. This plasma is enriched with growth factors, which are natural substances capable of stimulating cell growth and healing. The goal of using PRGF in this trial is to see if it can help heal foot ulcers in patients who have diabetes and peripheral arterial disease. The therapy is applied to the ulcer area, and researchers will evaluate its effectiveness in promoting healing over a period of six months.

Investigated diseases:

Diabetic foot

Foot ulcers in diabetic patients with peripheral arterial disease – This condition occurs when open sores develop on the feet of individuals who have diabetes and also suffer from peripheral arterial disease. The ulcers form due to poor blood circulation and nerve damage, which are common complications of diabetes. As the disease progresses, these ulcers can become larger and deeper, making them more difficult to heal. The lack of adequate blood flow impairs the body’s ability to fight infection and repair tissue, leading to prolonged healing times. If not properly managed, these ulcers can lead to further complications, including infection and tissue damage. Regular monitoring and care are essential to prevent the worsening of the condition.

Trial ID:

2023-504275-24-01

Protocol code:

BTIIMD-01-EC-23-PIED

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Use of Plasma Rich in Growth Factors for Treating Foot Ulcers in Diabetic Patients with Peripheral Arterial Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?