NCT02616263

Muscle, Joint and Movement Deterioration Contributing to Neuropathic Forefoot Deformity

Completed NA Results posted Last updated 22 November 2024

What this trial tests

NA trial testing Foot exercise in Diabetes Mellitus (DM) in 60 participants. Completed in 29 June 2021.

Timeline

1 March 2016

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	60
Start date	1 March 2016
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Foot exercise
• Shoulder exercise

Conditions studied

• Diabetes Mellitus (DM) — all drugs for Diabetes Mellitus (DM) →

Sponsor

Washington University School of Medicine

Who can join

Adults 40 to 75, any sex, with Diabetes Mellitus (DM). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period
  Time frame: Three years
  The angle between the 2nd metatarsal and the proximal phalanx will be measured at baseline and again at the 3-years

Sponsor's own description

The purpose of this research study is to determine the relationships between foot muscle, foot motion, and toe deformity. Results from this investigation will help the investigators to understand what contributes to foot deformities and the role of the foot muscles in the development of foot deformities. This could potentially guide treatment options focusing on strengthening the foot muscles to prevent or reduce the risk of developing a foot deformity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Heel Rise and Non-Weight-Bearing Ankle Plantar Flexion Tasks to Assess Foot and Ankle Function in People With Diabetes Mellitus and Peripheral Neuropathy.
   Jeong HJ, Mueller MJ, Zellers JA, Yan Y, et al · · 2021 · cited 8× · PMID 33735386 · DOI 10.1093/ptj/pzab096
2. Midfoot and ankle motion during heel rise and gait are related in people with diabetes and peripheral neuropathy.
   Jeong HJ, Mueller MJ, Zellers JA, Hastings MK. · · 2021 · cited 8× · PMID 33264731 · DOI 10.1016/j.gaitpost.2020.11.013
3. Multi-System Factors Associated with Metatarsophalangeal Joint Deformity in Individuals with Type 2 Diabetes.
   Zellers JA, Mueller MJ, Commean PK, Chen L, et al · · 2020 · cited 8× · PMID 32260124 · DOI 10.3390/jcm9041012
4. Remote Research: Resources, Intervention Needs, and Methods in People with Diabetes and Peripheral Neuropathy.
   Bohnert KL, Zellers JA, Jeong HJ, Chen L, et al · · 2023 · cited 5× · PMID 35770988 · DOI 10.1177/19322968221103610
5. A limited number of slices yields comparable results to all slices in foot intrinsic muscle deterioration ratio on computed tomography and magnetic resonance imaging.
   Zellers JA, Commean PK, Chen L, Mueller MJ, et al · · 2021 · cited 5× · PMID 34555631 · DOI 10.1016/j.jbiomech.2021.110750
6. Association of toe-extension movement pattern magnitude and variability during three functional tasks with diabetic foot complications.
   Zellers JA, Bernhardson HJ, Jeong HJ, Commean PK, et al · · 2021 · cited 4× · PMID 33965738 · DOI 10.1016/j.clinbiomech.2021.105371
7. Body mass index and maximum available midfoot motion are associated with midfoot angle at peak heel rise in people with type 2 diabetes mellitus and peripheral neuropathy.
   Jeong HJ, Mueller MJ, Zellers JA, Commean PK, et al · · 2022 · cited 3× · PMID 35255403 · DOI 10.1016/j.foot.2022.101912
8. Relationships within and between lower and upper extremity dysfunction in people with diabetes.
   Hastings MK, Jeong HJ, Sorensen CJ, Zellers JA, et al · · 2020 · cited 3× · PMID 32679515 · DOI 10.1016/j.foot.2020.101680