RECRUITING

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

Official Title

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Quick Facts

Study Start:2023-12-13

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05603273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Provision of signed and dated informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or Female, aged 18 yrs or older 4. Diabetes diagnosed or meets ADA criteria for Type 2 diabetes 5. Foot ulcer of diabetic etiology, with all of the following characteristics: * Ulcer size \> 0.5cm2 and \< 12cm2 at least 2 cm from any other ulcer * Ulcer with Wagner grade 1 or 2 6. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.	1. Patient participating in an interventional clinical trial within 1 month of visit 1 2. Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading 3. Participant has active severe infection or osteomyelitis at the time of the screening visit 4. History of cancer within the last 3 years, other than non-melanoma skin cancer 5. Use of adjunctive therapy within previous 30 days 6. Currently receiving medication considered to be a systemic glucocorticoid 7. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention 8. Pregnant or currently lactating 9. Uncontrolled blood glucose with presence of urinary ketones 10. Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\] 11. Bilateral wound or ulcer 12. Current infection of COVID19 13. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study

Inclusion Criteria

Exclusion Criteria

1. Provision of signed and dated informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or Female, aged 18 yrs or older
4. Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
5. Foot ulcer of diabetic etiology, with all of the following characteristics:
* Ulcer size \> 0.5cm2 and \< 12cm2 at least 2 cm from any other ulcer
* Ulcer with Wagner grade 1 or 2
6. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.

1. Patient participating in an interventional clinical trial within 1 month of visit 1
2. Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
3. Participant has active severe infection or osteomyelitis at the time of the screening visit
4. History of cancer within the last 3 years, other than non-melanoma skin cancer
5. Use of adjunctive therapy within previous 30 days
6. Currently receiving medication considered to be a systemic glucocorticoid
7. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention
8. Pregnant or currently lactating
9. Uncontrolled blood glucose with presence of urinary ketones
10. Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\]
11. Bilateral wound or ulcer
12. Current infection of COVID19
13. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study

Contacts and Locations

Study Contact

Jacob Haus, PhD

CONTACT

734 647 2790

jmhaus@umich.edu

Principal Investigator

Jacob Haus, PhD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

School of Kinesiology

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Jacob Haus, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-12-13

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Type2diabetes
Foot Ulcer