Peripheral Arterial Disease Trial, Recruiting NCT05437562 Sponsor: VA Office of Research and Development Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT05437562
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a Veteran with enough blood flow in your leg (shown by a detectable pulse behind the knee or in the upper thigh with a signal behind the knee) to allow healing after a below-the-knee amputation
  • You are willing and expected to take part in rehabilitation and learn to walk again after the amputation, based on your own interest, your recent ability to walk, and an assessment by a physical therapy team
  • You are scheduled for a below-the-knee amputation for a reason other than infection, OR you have had a foot infection that stayed below the ankle, was fully cleaned out, and was treated with the right antibiotics

Who may not be able to join:

  • Veterans who have end-stage kidney (renal) disease
  • Veterans who need a major amputation because of an infection that has spread to or above the ankle area
  • Veterans whose blood flow is not strong enough to allow the amputation wound to heal properly
  • Veterans who are unable to take part in rehabilitation or are not expected to be able to walk with a prosthetic (artificial) limb for any reason
  • Veterans who have already been enrolled in this trial for their other leg (to avoid one person having two different types of amputation as part of the study)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Luke P Brewster, MD, Atlanta VA Medical and Rehab Center, Decatur, GA

Phone: (404) 321-6111

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
2 February 2026
Est. completion
2 February 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

PROMIS Numeric Rating Scale; Socket Comfort Score; Phantom and Residual Limb Questionnaire; Lower Extremity Amputee Data Collection Form; Lower Limb Mobility Rating Scale; Amputee Single Item Mobility Measure; Activities-specific Balance Scale; Self-Reported Falls Measure; RAND Health Survey; CRIS Fixed Form Instrument; Patient Two Minute Walk Test; Patient Timed Up and Go Test; Berg Balance Scale; Amputee Mobility Predictor Questionnaire

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov