Metatarsal Phalangeal Joint Deformity Progression - R01

November 22, 2024 updated by: Mary Hastings, PT, DPT, ATC, Washington University School of Medicine

Muscle, Joint and Movement Deterioration Contributing to Neuropathic Forefoot Deformity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long term goal of this research is to reduce the incidence of lower extremity amputation in people with diabetes mellitus and peripheral neuropathy. It is hypothesized that muscle, joint, and movement deterioration associated with diabetes and peripheral neuropathy contribute to metatarsophalangeal joint (MTPJ) hyperextension deformity. MTPJ deformity results in excessive plantar stress on the insensitive forefoot, leading to ulceration and amputation. However, the specific cause of MTPJ deformity is not clear. The overall goal of this proposal is to identify the causes of MTPJ deformity and examine the ability of a targeted foot specific intervention to de-couple diabetes related mechanisms from MTPJ deformity and progression, following participants for 3 years. The investigators hypothesize that the cause of MTPJ deformity is an interaction of the accumulation of advanced glycation end products, muscle deterioration, limited joint mobility and compensatory movement strategies.

The specific aims are to determine:

  1. relationships between advanced glycation end products, intrinsic foot muscle volume, limited ankle dorsiflexion joint mobility, MTPJ hyperextension movement pattern, and MTPJ alignment;
  2. estimate the effect of a foot specific intervention on the MTPJ extension alignment and
  3. determine progression of MTPJ deformity and the predictors of progression over three years.

The following will be collected on participants with diabetes mellitus and peripheral neuropathy and monitored over three years to understand the causes and progression of MTPJ deformity:

  1. Skin intrinsic florescence to measure advanced glycation end product accumulation which increases collagen cross-linking and is associated with peripheral neuropathy, limited joint mobility, and muscle deterioration.
  2. Magnetic resonance images to measure intrinsic foot muscle deterioration that precedes extrinsic foot muscle deterioration as a result of distal to proximal peripheral neuropathy. The muscle imbalance of weak intrinsic foot muscles, the only muscles able to flex the MTPJ, in the presence of relatively stronger extrinsic toe extensors, results in a force couple that hyperextends the MTPJ.
  3. Kinematic and computed tomography measurement of foot and ankle joint positions to examine mobility and movement patterns that contribute to repeated and extreme MTPJ hyperextension during daily activities.

The investigators believe advanced glycation end products lead to limited ankle joint dorsiflexion. As a result, there is increased reliance on the extensor digitorum longus to assist in dorsiflexing the stiff ankle joint during activities like sit to stand. This study will have profound implications for reducing risk for skin breakdown and amputation by helping to understand and treat the causes of acquired neuropathic foot deformities. A successful foot specific intervention that improves MTPJ alignment will provide a non-invasive option to halt or slow the cascade of events leading to major lower extremity amputation, while improving function and minimizing disability.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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<0.9 or >1.3), with fixed MTPJ deformity (excursion <30 degrees active/passive), acute shoulder pain or disability that would prevent participation in shoulder specific intervention (i.e. severe shoulder pain >6/10, rotator cuff tear, upper extremity surgery, thoracic outlet syndrome);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot Intervention
The intervention is a progressive, home based exercise program aimed to increase ankle and foot plantarflexion muscle strength, increase ankle dorsiflexion and toe flexion range of motion, and to retrain individuals to dorsiflex the ankle while keeping the toes in a neutral position. A trained physical therapist with experience working with older adults with diabetes and foot specific complications will monitor and progress the exercise program assuring participant safety and maximizing exercise benefit.
Other: Foot exercise
Active Comparator: Shoulder Intervention
Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation and a tailored dose of active shoulder motion.
Other: Shoulder exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Mary K Hastings, PT,DPT,MSCI, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimated)

November 26, 2015

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK107809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Other researchers may contact us to get access to the data but we will not be placing the data in a repository

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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