Status:
NOT_YET_RECRUITING
Comparing Wound Complication Following TMA With Aid of Electrospun Fiber Matrix
Lead Sponsor:
Scripps Health
Collaborating Sponsors:
North Park Podiatry
Conditions:
Amputation
Wound; Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a syn...
Detailed Description
Intervention or Exposure * Transmetatarsal amputation with application of synthetic electrospun fiber matrix * After surgery, patient will be off-loaded to the surgical site with an off-loading devic...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06063694
Start Date
March 1 2024
End Date
November 1 2024
Last Update
March 5 2024
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