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Structured Exercise Program for Diabetic Foot

N/A
Recruiting
Led By Eric J Lew, DPM
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 2 diabetes
DFU of WIfI Grade 2 or less
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks or less
Awards & highlights

Study Summary

This trial will test if exercise can help heal foot ulcers for type 2 diabetics.

Who is the study for?
This trial is for Type 2 diabetics aged 20-80 with foot ulcers (WIfI stage 2 or lower). Participants must have stable blood glucose and HbA1c levels, be able to communicate in English or Spanish, and have reliable transportation. Those with infections, without medical clearance, unable to consent, immunocompromised individuals, or prisoners cannot join.Check my eligibility
What is being tested?
The study tests if a structured exercise program speeds up wound healing in diabetic foot ulcers. It's conducted through an outpatient cardiac rehab setup. The main measure is how quickly the ulcer reaches the maturation phase—meaning it's closed and not draining.See study design
What are the potential side effects?
While specific side effects are not listed for exercising as part of this trial, typical risks might include muscle soreness, fatigue, low blood sugar episodes for diabetics during physical activity, and potential stress on the heart.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.
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My foot ulcer is not severe, graded 2 or less.
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I am between 20 and 80 years old.
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I can read and speak English or Spanish fluently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks or less
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks or less 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 healing time

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment-as-usual plus medically-supervised exercise (TAU-EX)Experimental Treatment1 Intervention
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.
Group II: Treat-as-usual (TAU)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor
371 Previous Clinical Trials
3,528,841 Total Patients Enrolled
Ann L Gibson, PhDStudy ChairUniversity of New Mexico
Eric J Lew, DPMPrincipal InvestigatorUniversity of New Mexico Health Sciences Center

Media Library

Structured exercise program Clinical Trial Eligibility Overview. Trial Name: NCT04791449 — N/A
Foot Ulcer Research Study Groups: Treatment-as-usual plus medically-supervised exercise (TAU-EX), Treat-as-usual (TAU)
Foot Ulcer Clinical Trial 2023: Structured exercise program Highlights & Side Effects. Trial Name: NCT04791449 — N/A
Structured exercise program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791449 — N/A

Frequently Asked Questions

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

Do I satisfy the prerequisites to participate in this trial?

"This medical research requires 60 participants aged between 20 and 80 with diabetic foot."

Answered by AI

Are there still openings in this clinical research endeavor?

"The clinical trial data hosted on clinicaltrials.gov shows that patient recruitment is still taking place for this medical study, which was first announced October 10th 2021 and last updated May 16th 2022."

Answered by AI

Can seniors aged 60 and above join in this research endeavor?

"This experiment is recruiting participants who are within the range of 20 to 80 years old."

Answered by AI

What is the scope of participants in this research study?

"Affirmative. Clinicaltrials.gov data confirms that the study is actively seeking participants, which was first listed on October 10th 2021 and recently updated on May 16th 2022. Up to 60 individuals must be recruited at a single clinical site."

Answered by AI
Recent research and studies
~20 spots leftby May 2025