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New treatment option for Diabetic Complications
Official title Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
ClinicalTrials.gov ID: NCT07620379
What this study is testing
- What it's testing
- The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers. The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Aged between 55 and 75.
- Diagnosis of diabetes mellitus.
- Patients with an ankle-brachial index of \>0.8 and \<1.2.
- Signature of the informed consent form
You likely can't join if
- Leg or foot injuries or ulcers that cause pain and prevent normal movement in both lower limbs.
- Foot trauma within the last month.
- Inability to adhere to the full schedule of measurements required by the study.
- Participants who do not sign the informed consent form.
- Known contact dermatitis to any of the study materials
The study team makes the final eligibility decision.
Where it's taking place
- Valencia, Valencia, 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, 55 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valencia, Valencia, 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.