Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix

Launched by SCRIPPS HEALTH · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to improve the healing process for patients who are undergoing a specific type of foot amputation called transmetatarsal amputation (TMA). Many patients experience complications and slow healing after this surgery, and researchers want to see if using a special synthetic material called an electrospun fiber matrix can help reduce infections and improve healing. This material is designed to mimic the structure of natural tissue and has shown promise in other studies for healing wounds.

To participate in the trial, you need to be at least 18 years old and scheduled for a TMA. You'll also need to show that your blood flow to the foot is adequate, which can be tested in various ways. If you're pregnant, currently undergoing cancer treatment, or have certain allergies or health conditions, you may not be eligible. If you join the study, you can expect to be part of a process that aims to improve wound healing and reduce complications after surgery. It’s important to know that the trial is not yet recruiting participants, so you may need to wait for it to start.

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Eligibility criteria

• Inclusion Criteria:
• • Undergoing TMA
• • At least 18 years old
• • Adequate perfusion demonstrated by either TcPO2 or ankle-brachial index (ABI) or toe-brachia index (TBI) within 60 days prior to enrollment/randomization (Dorsum TcPO2 of study leg(s) ≥40mmHg OR ABI of study leg(s) with results of ≥ 0.7 and ≤ 1.3 OR TBI of study extremity(ies) with results of ≥ 0.5).
• • Patient is willing and capable of complying with all protocol requirements.
• • Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to any study procedures
• Exclusion Criteria:
• • Previously enrolled into this study or is currently participating in another prospective drug or device study that has not reached its primary endpoint.
• • Patient is pregnant, breast feeding or planning to become pregnant.
• • Patient has a known allergy to resorbable suture materials.
• • Patient has a life expectancy less than three months as assessed by the investigator.
• • Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period.
• • Patient currently undergoing cancer treatment.
• • Patient diagnosed with autoimmune connective tissue.
• • Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period.
• • Chronic oral steroid use is not excluded if dose is \<10 mg per day for prednisone.
• • Patient unwilling or unable to safely utilize appropriate offloading device to unweight wound(s).