NCT04791449 · University of New Mexico
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
What this study is about
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.
View original scientific description
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).
Interventions
OTHER
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 measures
wound healing time
Time frame: 12 weeks or less
number of days from enrollment required to reach the maturation phase of the wound healing cascade (wound closure without drainage)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Albuquerque, New Mexico
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations