Exercise improves healing of diabetic foot ulcers
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
This study is testing if a 12-week exercise program can help people with Type 2 diabetes heal their foot ulcers faster compared to just standard wound care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT04791449 on ClinicalTrials.gov |
What this trial studies
This study investigates how a medically supervised exercise program affects the healing of diabetic foot ulcers in patients with Type 2 diabetes. It involves recruiting sixty participants from the University of New Mexico's Center for Healing in the Lower Extremity clinic, who will be randomly assigned to either standard wound care or standard care plus a 12-week exercise program. The primary measure of success will be the time taken for the ulcers to reach the maturation phase of healing. Participants will be screened for eligibility based on specific health criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 with Type 2 diabetes and diabetic foot ulcers classified as WIfI stage 2 or lower.
Not a fit: Patients who are immunocompromised, have infections, or cannot provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the healing process for patients with diabetic foot ulcers.
How similar studies have performed: Previous studies have shown that exercise can positively impact wound healing, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Albuquerque, New Mexico
- UNM Cardiac Rehabilitation Services — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Eric J Lew, DPM — University of New Mexico Health Sciences Center
- Study coordinator: Ann L Wells, PhD
- Email: AnLWells@salud.unm.edu
- Phone: 505-272-4107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.