Clinical trial NCT02233140: Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure
Official title: Do Physical Manipulation Exercises With EPAT Improve Ankle Dorsiflexion and Reduce Dynamic Plantar Forefoot Pressure in Diabetic Subjects With Equinus?: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Equinus Contracture of the Ankle
Keywords: Diabetes
Ankle equinus
ankle dorsiflexion
dynamic plantar pressure
shockwave therapy
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
timeFrame: at baseline visit and at 4 weeks
measure: Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.
timeFrame: at baseline visit and 4 weeks
Secondary outcomes:
measure: Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
timeFrame: at 1 month and at 3 months
measure: Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from 1 month to 3 months.
timeFrame: at 1 month and at 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gait Study Center at the Temple University School of Podiatric Medicine
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Jinsup Song, DPM, PhD
role: PRINCIPAL_INVESTIGATOR
References: