DiabetesNCT02233140
Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure
A study testing Extra-corporeal pulsed-activated therapy or shockwave therapy in people with Diabetes and Equinus Contracture of the Ankle, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes, Equinus Contracture of the Ankle
- What is being tested?
- Extra-corporeal pulsed-activated therapy or shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gait Study Center at the Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Jinsup Song, D.P.M., Ph.D., 215-625-5369, jsong@temple.edu
Jinsup Song, D.P.M., Ph.D.
About this study
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
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.
- Conditions
- Diabetes, Equinus Contracture of the Ankle
- Being tested
- Extra-corporeal pulsed-activated therapy or shockwave therapy
- Keywords
- Diabetes, Ankle equinus, ankle dorsiflexion, dynamic plantar pressure, shockwave therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-corporeal pulsed-activated therapy or shockwave therapyDevice
Also called D-Actor® 200
| Study group | Role | What they receive |
|---|---|---|
| Shockwave with manual manipulation | Experimental | A shockwave (EPAT) therapy with two supervised manual manipulation per week Receives: Device: Extra-corporeal pulsed-activated therapy or shockwave therapy |
| Manual manipulation | Active comparator | A Placebo (no) shockwave with two supervised manual manipulations per week Receives: Device: Extra-corporeal pulsed-activated therapy or shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
Measured: at baseline visit and at 4 weeks
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.
Measured: at baseline visit and 4 weeks
Secondary outcomes (2)
Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
Measured: 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.
Measured: at 1 month and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinsup Song, DPM, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233140
- Sponsor's protocol ID
- 21660
- Status last verified
- Aug 2015
- First submitted
- 28 Aug 2014
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02233140
- Acronym / sponsor ID
- 21660
- Conditions
- Diabetes, Equinus Contracture of the Ankle
- Keywords
- Diabetes, Ankle equinus, ankle dorsiflexion, dynamic plantar pressure, shockwave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave with manual manipulation | Experimental | Device: Extra-corporeal pulsed-activated therapy or shockwave therapyA shockwave (EPAT) therapy with two supervised manual manipulation per week |
| Manual manipulation | Active comparator | Device: Extra-corporeal pulsed-activated therapy or shockwave therapyA Placebo (no) shockwave with two supervised manual manipulations per week |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-corporeal pulsed-activated therapy or shockwave therapyAlso: D-Actor® 200 | Device | Manual manipulation, Shockwave with manual manipulation |
Primary outcome
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks
Time frame: at baseline visit and at 4 weeks
Change in dynamic peak plantar pressure (sub-metatarsal 2) in barefoot walking from baseline to 4 weeks.
Time frame: at baseline visit and 4 weeks
2 secondary outcomes
Change in maximum ankle dorsiflexion (lunge test) from 1 month to 3 months.
Time frame: 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.
Time frame: at 1 month and at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinsup Song, DPM, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-corporeal pulsed-activated therapy or shockwave therapy in people with Diabetes and Equinus Contracture of the Ankle, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsup Song, D.P.M., Ph.D. (215-625-5369, jsong@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum ankle dorsiflexion (lunge test) from baseline to 4 weeks (time frame: at baseline visit and at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.