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Non-weight Bearing Exercise for Diabetic Foot Ulcers

N/A
Recruiting
Led By Jacob Haus, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
Foot ulcer of diabetic etiology, with 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will study if exercise helps diabetic foot ulcers heal faster than standard wound care. Eligible participants must have an existing foot ulcer and be medically cleared to exercise.

Who is the study for?
This trial is for adults over 18 with Type 2 diabetes and a diabetic foot ulcer between 0.5cm² and 12cm², not complicated by infection or severe conditions. Participants must be able to exercise safely, have no recent vascular interventions, and not be on systemic glucocorticoids or involved in other trials.Check my eligibility
What is being tested?
The study tests if non-weight bearing exercises can speed up healing of diabetic foot ulcers compared to standard care alone. Over six weeks, participants will either perform these exercises along with receiving standard wound care or just receive the standard care.See study design
What are the potential side effects?
While specific side effects are not listed for non-weight bearing exercises, typical risks may include muscle soreness, fatigue, and potential stress on unaffected areas due to altered movement patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Type 2 diabetes.
Select...
I have a diabetic foot ulcer between 0.5cm2 and 12cm2, not close to other ulcers, and it's graded Wagner 1 or 2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
wound size and depth
Secondary outcome measures
blood flow

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: non-weight bearing exercise + standard wound careExperimental Treatment1 Intervention
normal wound care according to current clinical practice with the addition of a weekly exercise routine
Group II: standard wound careActive Control1 Intervention
normal wound care according to current clinical practice

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,942 Total Patients Enrolled
7 Trials studying Foot Ulcer
6,263 Patients Enrolled for Foot Ulcer
Jacob Haus, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Non-weight Bearing Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05603273 — N/A
Foot Ulcer Research Study Groups: standard wound care, non-weight bearing exercise + standard wound care
Foot Ulcer Clinical Trial 2023: Non-weight Bearing Exercise Highlights & Side Effects. Trial Name: NCT05603273 — N/A
Non-weight Bearing Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603273 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be fulfilled to join this clinical trial?

"This medical trial seeks to recruit forty individuals with foot ulcer between eighteen and seventy-five years old. In order to be considered, applicants should meet all the following eligibility requirements: gender (male or female), age above 18, diabetes diagnosis that meets American Diabetes Association criteria for Type 2 diabetes, Wagner grade 1/2 ulcers measuring more than 0.5 cm² but less than 12 cm² and located at least two centimeters away from other lesions in case of multiples; plus providing a signed informed consent form as well as willingness to comply with study procedures throughout the duration."

Answered by AI

Is this research endeavor presently open to recruitment?

"According to clinicaltrials.gov, this research project is currently open for participants since it was first posted on October 26th 2022 and last modified on the 31st of the same month."

Answered by AI

How many research participants are engaged in this investigation?

"Affirmative. From the clinicaltrials.gov website, we can see that this medical trial is presently accepting participants - it was initially posted on October 26th 2022 and has since been amended on October 31st 2022. The study seeks to enlist 40 individuals from one location for their research purposes."

Answered by AI

Is this trial open to those over the age of twenty years old?

"This medical trial is available to people aged between 18 and 75, with 51 trials for minors and 356 for those over 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Jacob Haus 2023. "Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05603273.
~27 spots leftby Jun 2025
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