NCT04791449

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
110mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Oct 2021May 2035

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2035

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

13.6 years

First QC Date

March 4, 2021

Last Update Submit

June 2, 2025

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • wound healing time

    number of days from enrollment required to reach the maturation phase of the wound healing cascade (wound closure without drainage)

    12 weeks or less

Study Arms (2)

Treatment-as-usual plus medically-supervised exercise (TAU-EX)

EXPERIMENTAL

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

Treat-as-usual (TAU)

NO 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.

Interventions

Structured exercise programOTHER

Medically-supervised participation in 2-3 exercise sessions per week over 12-wk study period. Exercise conducted in the cardiac rehabilitation program.

Treatment-as-usual plus medically-supervised exercise (TAU-EX)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of type 2 diabetes
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNM Cardiac Rehabilitation Services

Albuquerque, New Mexico, 87106, United States

RECRUITING

Related Publications (10)

  • Bloor CM. Angiogenesis during exercise and training. Angiogenesis. 2005;8(3):263-71. doi: 10.1007/s10456-005-9013-x. Epub 2005 Nov 19.

    PMID: 16328159BACKGROUND

  • Byrne AM, Bouchier-Hayes DJ, Harmey JH. Angiogenic and cell survival functions of vascular endothelial growth factor (VEGF). J Cell Mol Med. 2005 Oct-Dec;9(4):777-94. doi: 10.1111/j.1582-4934.2005.tb00379.x.

    PMID: 16364190BACKGROUND

  • Colwell AS, Beanes SR, Soo C, Dang C, Ting K, Longaker MT, Atkinson JB, Lorenz HP. Increased angiogenesis and expression of vascular endothelial growth factor during scarless repair. Plast Reconstr Surg. 2005 Jan;115(1):204-12.

    PMID: 15622252BACKGROUND

  • Keylock T, Young H. Delayed wound healing: can exercise accelerate it? International Journal of Exercise Science 3(3): 70-78, 2010.

    BACKGROUND

  • Riebe D. et al. ACSM's Guidelines for Exercise Testing and Prescription 10th ed. Philadelphia (PA). Wolters Kluwer; 2018.

    BACKGROUND

  • Eraydin S, Avsar G. The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. J Wound Ostomy Continence Nurs. 2018 Mar/Apr;45(2):123-130. doi: 10.1097/WON.0000000000000405.

    PMID: 29521922BACKGROUND

  • Arena R, Lavie CJ, Cahalin LP, Briggs PD, Guizilini S, Daugherty J, Chan WM, Borghi-Silva A. Transforming cardiac rehabilitation into broad-based healthy lifestyle programs to combat noncommunicable disease. Expert Rev Cardiovasc Ther. 2016;14(1):23-36. doi: 10.1586/14779072.2016.1107475. Epub 2015 Oct 29.

    PMID: 26511659BACKGROUND

  • Pence BD, DiPietro LA, Woods JA. Exercise speeds cutaneous wound healing in high-fat diet-induced obese mice. Med Sci Sports Exerc. 2012 Oct;44(10):1846-54. doi: 10.1249/MSS.0b013e31825a5971.

    PMID: 22543735BACKGROUND

  • Matos M, Mendes R, Silva AB, Sousa N. Physical activity and exercise on diabetic foot related outcomes: A systematic review. Diabetes Res Clin Pract. 2018 May;139:81-90. doi: 10.1016/j.diabres.2018.02.020. Epub 2018 Feb 23.

    PMID: 29477503BACKGROUND

  • Emery CF, Kiecolt-Glaser JK, Glaser R, Malarkey WB, Frid DJ. Exercise accelerates wound healing among healthy older adults: a preliminary investigation. J Gerontol A Biol Sci Med Sci. 2005 Nov;60(11):1432-6. doi: 10.1093/gerona/60.11.1432.

    PMID: 16339330BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Eric J Lew, DPM

    University of New Mexico Health Sciences Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann L Wells, PhD

CONTACT

505-272-4107AnLWells@salud.unm.edu

Eric J Lew, DPM

CONTACT

505-272-4107EJLew@salud.unm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Podiatrist and wound care technician will be blinded to an individual's participation and group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is based on a two-group repeated measures design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Eric J. Lew, MD

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

October 10, 2021

Primary Completion (Estimated)

May 31, 2035

Study Completion (Estimated)

May 31, 2035

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)