N/A N=60 Randomized Single-blind Other

Metatarsal Phalangeal Joint Deformity Progression - R01

Diabetes Mellitus (DM)

Bottom Line

View on ClinicalTrials.gov: NCT02616263 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period — 0.8; -0.1 degrees

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Foot exercise (Other); Shoulder exercise (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Metatarsal Phalangeal Joint Angle (Degrees) in People With Diabetes From Baseline and at a 3-year Period	0.8; -0.1	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Type 2 Diabetes Mellitus (DM)
Diabetic peripheral neuropathy

Exclusion Criteria

active plantar ulcers, unable to ambulate or complete required testing, anyone who have amputations of their lower extremity (>1 toe), weigh more than 400 lbs, pregnant, have metal implants or pace makers (incompatible with MRI), greater than 75 years old, Subjects with other causes of PN (lumbar radiculopathy, microvascular disease, alcoholic/HIV/chemotaxic neuropathy), on dialysis, with peripheral arterial disease (ABI 1.3), with fixed MTPJ deformity (excursion 6/10, rotator cuff tear, upper extremity surgery, thoracic outlet syndrome);

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02616263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.