Recruiting

Exercise

Sponsor:

University of New Mexico

Code:

NCT04791449

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Structured exercise program

Study Details

Brief summary:

The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade (wound closure without drainage).

Conditions

Diabetic Foot Ulcer

Study ID

NCT04791449

Start date

Oct 10, 2021

Status verified date

Jun, 2026

Completion date

May 31, 2035

Anticipated

Primary completion date

May 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosis of type 2 diabetes
  • 20 - 80 years of age
  • Ankle-Brachial Index (ABI) > 0.6 or Toe Pressure (TcPO2) > 40 mmHg
  • recent (within 12 weeks) blood glucose value between 100 - 350 mg/dL
  • recent (within 12 weeks) HbA1c value < 14 %,
  • DFU of WIfI Grade 2 or less
  • fluency in reading and speaking English or Spanish.

Exclusion Criteria:

  • inability to provide own consent
  • inability to obtain permission to participate from a medical professional
  • lack of consistent mode of transportation to UNMH
  • infection to any part of the body
  • patients that has had a transplant and/or is immunocompromised
  • prisoners.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment-as-usual plus medically-supervised exercise (TAU-EX)

This group attends normal wound care appointments as scheduled with the wound care provider, generally 2 - 3 times per week. Coincident with these appointments, ideally, they will also attend a medically-supervised exercise program supervised by the exercise physiologists of the Cardiac Rehabilitation facility. The exercise sessions will last no more than 1-hr per session. The maximum number of sessions possibly attended over the 12-wk intervention period is 36. In addition, participants in this group will maintain their activities of daily life unless contraindicated by the would care provider.

no intervention: Treat-as-usual (TAU)

This group attends normal wound care appointments as scheduled with the wound care provider, generally 2 - 3 times per week. In addition, participants in this group will maintain their activities of daily life unless contraindicated by the would care provider.

Interventions

Structured exercise program

Medically-supervised participation in 2-3 exercise sessions per week over 12-wk study period. Exercise conducted in the cardiac rehabilitation program.

Primary outcome measure

  • wound healing time [ Time Frame: 12 weeks or less ]

Central Contacts and Locations

Central contacts

Ann L Wells, PhD

505-272-4107AnLWells@salud.unm.edu

Eric J Lew, DPM

505-272-4107EJLew@salud.unm.edu

Locations

UNM Cardiac Rehabilitation Services

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

La Tonji Peace

505-925-6772lpeace@salud.unm.edu

More Information

Sponsor

University of New Mexico

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-06-11.