Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorUniversity of New Mexico
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Structured exercise program
Other interventionMedically-supervised participation in 2-3 exercise sessions per week over 12-wk study period. Exercise conducted in the cardiac rehabilitation program.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Treatment-as-usual plus medically-supervised exercise (TAU-EX)Experimental treatment 1 intervention
Group B: Treat-as-usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
wound healing time
number of days from enrollment required to reach the maturation phase of the wound healing cascade (wound closure without drainage)
Time frame
12 weeks or lessSponsors and contacts
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Source ClinicalTrials.gov