PNS to Improve Vascular Function and Limb Health in Veterans

NCT ID
NCT07696988
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
VA Office of Research and Development

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 42 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: Inclusion Criteria - All Participants: * English-speaking * Veteran Inclusion Criteria - Diabetic Peripheral Neuropathy (DPN) Participants: * Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years * Clinical signs and/or symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam Inclusion Criteria - Lower Limb Amputees: * Unilateral transtibial or transfemoral amputation * Medically stable for at least 3 months * For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and/or tibial nerves Exclusion Criteria: Exclusion Criteria - All Participants: * Severe neurological disorders impairing ambulation * Visual or hearing impairments interfering with study participation * Cardiovascular or respiratory conditions posing risk during participation * Cognitive or psychiatric conditions compromising informed consent * Participation in other clinical trials interfering with outcomes * Pregnancy * History of photosensitivity or known sensitivity to laser light Additional Exclusion Criteria - Amputees: * Active skin breakdown or infection at residual limb * Significant phantom or residual limb pain interfering with study procedures * Bilateral lower-limb amputation

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Ohio, United States: 1

Sample of listed locations

  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, 44106-1702, United States — Site recruitment status not specified in the registry data

Study details

Start date
November 2, 2026
Primary completion date
May 30, 2030
First posted
July 10, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07696988
Registry last updated
August 21, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07696988 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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