Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

NARecruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 9, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic

Physical therapy evaluation (range of motion, strength, mobility, scale). Noraxon based gait assessment on treadmill while barefoot and with instrumented inner soles. Over ground walking assessment (with wireless instrumented inner soles, observational gait analysis while climbing stairs, ramps, curbs). Noraxon gait assessment and walking on treadmill will be video recorded for assessment. Standard measure of functionality and 6 minute walk test will be conducted. Patient will be fitted with corrective orthotics, based on usual care. Physical therapy re-evaluation. Noraxon based gait assessment and foot assessment (any areas of irritation, callus formation, swelling, ulcer formation, and gait mobility irregularities will be monitored and reassessed) throughout the study.

Trial Locations (1)

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

All Listed Sponsors
lead

Johns Hopkins University

OTHER