RecruitingNot ApplicableNCT04791449

Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers

Sponsor

University of New Mexico

Enrollment

60 participants

Start Date

Oct 10, 2021

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Ulcer

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).

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria7

diagnosis of type 2 diabetes
- 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 Criteria6

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.

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Interventions

OTHERStructured exercise program

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