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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
Sponsor:
Information provided by (Responsible Party):
Ann L. Gibson, University of New Mexico

Brief 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).

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: Structured exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Rachel O Landavazo, PA-C 505-263-8707 rlandavazo@salud.unm.edu
Contact: Ann L Gibson, PhD 505-277-2658 alg@unm.edu

Sponsors and Collaborators
University of New Mexico
Investigators
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Study Chair: Ann L Gibson, PhD University of New Mexico
Additional Information:
Publications:
Keylock T, Young H. Delayed wound healing: can exercise accelerate it? International Journal of Exercise Science 3(3): 70-78, 2010.
Riebe D. et al. ACSM's Guidelines for Exercise Testing and Prescription 10th ed. Philadelphia (PA). Wolters Kluwer; 2018.

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Responsible Party: Ann L. Gibson, Professor, Exercise Science, University of New Mexico
ClinicalTrials.gov Identifier: NCT04791449    
Other Study ID Numbers: 19-537
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases