Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure

Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02233140

Enrollment

Registered

2014-09-08

Start date

2014-10-31

Completion date

2017-10-31

Last updated

2015-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Equinus Contracture of the Ankle

Keywords

Diabetes, Ankle equinus, ankle dorsiflexion, dynamic plantar pressure, shockwave therapy

Brief summary

Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers. Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers. The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.

Interventions

DEVICEExtra-corporeal pulsed-activated therapy or shockwave therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Men and women between the ages of 21 to 65, inclusive * Diabetes, either type 1 or 2 * Ankle equinus (\< 0º passive ankle dorsiflexion with knee extended) * Forefoot plantar hyperkeratosis (callus) * Able to walk independently without the use of walking aids (cane, crutches, or walker) * Able to understand the information in the informed consent form and willing and able to comply with study-related procedures

Exclusion criteria

* Previous history of ankle-foot surgery or amputation * no active lower extremity skin ulcers * Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index \<0.8) * Not willing or able to make required visits * Nursing or pregnant * Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel, including discontinuation of icing, NSAIDs and natural anti-inflammatory agents (such as Arnica)

Design outcomes

Primary

Measure	Time frame
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks	at baseline visit and at 4 weeks
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.	at baseline visit and 4 weeks

Secondary

Measure	Time frame
Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.	at 1 month and at 3 months
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.	at 1 month and at 3 months

Countries

United States

Contacts

Primary ContactJinsup Song, D.P.M., Ph.D.

jsong@temple.edu215-625-5369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026