Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT04791449
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Oct 10, 2021
Status verified
Jun 2026
Primary completion
May 31, 2035
Completion
May 31, 2035

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNM Cardiac Rehabilitation ServicesAlbuquerqueNew Mexico87106
La Tonji Peace
[email protected]
505-925-6772

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By research site
UNM Cardiac Rehabilitation Services· Albuquerque, NM

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