Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT04791449|
Recruitment Status : Not yet recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Other: Structured exercise program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is based on a two-group repeated measures design.|
|Masking:||Single (Care Provider)|
|Masking Description:||Podiatrist and wound care technician will be blinded to an individual's participation and group assignment.|
|Official Title:||Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers|
|Estimated Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
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.
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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791449
|Contact: Rachel O Landavazo, PA-Cfirstname.lastname@example.org|
|Contact: Ann L Gibson, PhDemail@example.com|
|Study Chair:||Ann L Gibson, PhD||University of New Mexico|