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

Primary Purpose

Type2diabetes, Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-weight bearing exercise
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of KinesiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard wound care

non-weight bearing exercise + standard wound care

Arm Description

normal wound care according to current clinical practice

normal wound care according to current clinical practice with the addition of a weekly exercise routine

Outcomes

Primary Outcome Measures

wound size and depth
wound site and depth

Secondary Outcome Measures

blood flow
blood flow by ultrasound

Full Information

First Posted
October 26, 2022
Last Updated
August 24, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05603273
Brief Title
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Official Title
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This research is being done because people with diabetes have reduced healing capacity. This can be problematic because wounds that do not heal may turn into ulcers which may lead to more severe complications. Non-weight bearing exercise has many positive health benefits that improve metabolic and vascular health which will then improve healing time. Therefore, the purpose of this study is to evaluate the positive effects of non-weight bearing exercise. Once the effects of non-weight bearing exercise are confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible. Potential participants are eligible for the study if diagnosed with type 2 diabetes and have a foot ulcer or wound. Approximately 40 subjects with Type 2 Diabetes are expected to complete this study. Participation in this study requires medical clearance following a screening visit and then being randomly assigned to a non-weight bearing exercise training group or a control group. Both groups will receive standard diabetic and wound care. Subjects will complete 7 study visits at the University of Michigan. The research tests during these visits will include measures of body composition, oral glucose tolerance test, exercise testing, blood draws, vascular function measurements, wound measurement, single-leg exercise session and group randomization If randomized to the Exercise Group subjects will be asked to visit the University of Michigan three days a week for 6 weeks. During each visit during this 6-week period, subjects will perform exercise training by completing 30 minutes of single-leg exercise at approximately 50% of a predetermined maximal effort. Regardless of the group subjects are randomized to, all will receive standard care for the management of diabetes foot ulcer/wound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes, Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard wound care
Arm Type
No Intervention
Arm Description
normal wound care according to current clinical practice
Arm Title
non-weight bearing exercise + standard wound care
Arm Type
Experimental
Arm Description
normal wound care according to current clinical practice with the addition of a weekly exercise routine
Intervention Type
Behavioral
Intervention Name(s)
non-weight bearing exercise
Intervention Description
exercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks
Primary Outcome Measure Information:
Title
wound size and depth
Description
wound site and depth
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
blood flow
Description
blood flow by ultrasound
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent Stated willingness to comply with all study procedures and availability for the duration of the study Male or Female, aged 18 yrs or older Diabetes diagnosed or meets ADA criteria for Type 2 diabetes 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 In case of multiple ulcers, select the largest ulcer that meets inclusion criteria. Exclusion Criteria: Patient participating in an interventional clinical trial within 1 month of visit 1 Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading Participant has active severe infection or osteomyelitis at the time of the screening visit History of cancer within the last 3 years, other than non-melanoma skin cancer Use of adjunctive therapy within previous 30 days Currently receiving medication considered to be a systemic glucocorticoid Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or < 1 month from a prior ipsilateral (same side) vascular intervention Pregnant or currently lactating Uncontrolled blood glucose with presence of urinary ketones Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription [1] Bilateral wound or ulcer Current infection of COVID19 Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Haus, PhD
Phone
734 647 2790
Email
jmhaus@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Haus, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Kinesiology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Haus, PhD
Phone
734-763-3932
Email
jmhaus@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data at this time

Learn more about this trial

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

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