Ankle EquinusNCT01238484
Ankle Equinus Contracture Treated With Dynamic Splinting
A study testing Dynasplint in people with Ankle Equinus and Ankle Contracture, run by Dynasplint Systems, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ankle Equinus, Ankle Contracture, Diabetes Mellitus
- What is being tested?
- Dynasplint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Jan 2013
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous Diagnosis Diabetes Mellitus
- Reduced flexibility in AROM of extension in the ankle
- Less than 10º Maximal, Active Dorsiflexion, while upright
- Impaired gait pattern
Who cannot join
- Previous surgical treatment for this pathology
- Previous surgery of the Achilles tendon or triceps surae
- Current treatment with corticosteroids
- Current treatment with Botulinium Toxin-A (Botox), lower extremity
- Current treatment Fluoroquinolones (antibiotic medication)
- Current use of muscle relaxant medications
Show all 11Show fewer
- Fibromyalgia
- Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
- Current participation in manual, physical therapy
- Treatment with electrical stimulation assisting ambulation (i.e. Bioness, WalkAide, Parastep, etc.)
- Preexisting open sores on foot or leg
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lopez Ankle and Foot
Fort Worth, Texas, 76164
Atlanta Foot and Leg Clinic
Jonesboro, Georgia, 30236
About this study
Official title: Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.
- Conditions
- Ankle Equinus, Ankle Contracture, Diabetes Mellitus
- Being tested
- Standard of care, Dynasplint
- Keywords
- Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
shoe modification home stretching exercises
DynasplintDevice
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises. Receives: Other: Standard of care |
| Experimental | Experimental | Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint. Receives: Device: Dynasplint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
The primary outcome is change in ankle range of motion
Measured: 4 months
Secondary outcomes (1)
Pain
The secondary outcome will be change in pain scale rating as reported by patient
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Centers could not meet enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ankle EquinusStudies 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMurry University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238484
- Sponsor's protocol ID
- 2010:004
- Status last verified
- Jul 2013
- First submitted
- 9 Nov 2010
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Gils CC, Roeder B. The effect of ankle equinus upon the diabetic foot. Clin Podiatr Med Surg. 2002 Jul;19(3):391-409, vi. doi: 10.1016/s0891-8422(02)00010-1.
PubMed 12379973Lavery LA, Armstrong DG, Boulton AJ; Diabetex Research Group. Ankle equinus deformity and its relationship to high plantar pressure in a large population with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):479-82. doi: 10.7547/87507315-92-9-479.
PubMed 12381796Armstrong DG, Boulton AJ. Continuous Internet-based activity monitoring provides a surrogate marker for nocturnal polyuria in persons with diabetes mellitus at high risk for foot ulceration. Diabet Med. 2002 Dec;19(12):1034-5. doi: 10.1046/j.1464-5491.2002.00696_2.x. No abstract available.
PubMed 12647847Dananberg HJ, Shearstone J, Guillano M. Manipulation method for the treatment of ankle equinus. J Am Podiatr Med Assoc. 2000 Sep;90(8):385-9. doi: 10.7547/87507315-90-8-385.
PubMed 11021048Lopez AA, Kalish SR, John MM, Willis FB. Reduction of Ankle Equinus Contracture Secondary to Diabetes Mellitus with Dynamic Splinting. Foot & Ankle Online Journal. 2010 3(3):13-18
Birke JA, Patout CA Jr, Foto JG. Factors associated with ulceration and amputation in the neuropathic foot. J Orthop Sports Phys Ther. 2000 Feb;30(2):91-7. doi: 10.2519/jospt.2000.30.2.91.
PubMed 10693087Wallny T, Brackmann H, Kraft C, Nicolay C, Pennekamp P. Achilles tendon lengthening for ankle equinus deformity in hemophiliacs: 23 patients followed for 1-24 years. Acta Orthop. 2006 Feb;77(1):164-8. doi: 10.1080/17453670610045867.
PubMed 16534718Grady JF, Saxena A. Effects of stretching the gastrocnemius muscle. J Foot Surg. 1991 Sep-Oct;30(5):465-9.
PubMed 1783755Bowers AL, Castro MD. The mechanics behind the image: foot and ankle pathology associated with gastrocnemius contracture. Semin Musculoskelet Radiol. 2007 Mar;11(1):83-90. doi: 10.1055/s-2007-984418.
PubMed 17665354Mullaney MJ, McHugh MP, Tyler TF, Nicholas SJ, Lee SJ. Weakness in end-range plantar flexion after Achilles tendon repair. Am J Sports Med. 2006 Jul;34(7):1120-5. doi: 10.1177/0363546505284186. Epub 2006 Feb 13.
PubMed 16476917Chen L, Greisberg J. Achilles lengthening procedures. Foot Ankle Clin. 2009 Dec;14(4):627-37. doi: 10.1016/j.fcl.2009.08.002.
PubMed 19857837Lai J, Jones M, Willis B. Effect of Dynamic Splinting on Excessive Plantar Flexion Tone/Contracture: A Controlled, Cross-Over study. Proceedings of the 16th European Congress of Physical and Rehabilitation Medicine. Minerva Medica pubs, Italy, August 2008, pg 106-109.
Lundequam P, Willis FB. Dynamic splinting home therapy for toe walking: a case report. Cases J. 2009 Nov 10;2:188. doi: 10.1186/1757-1626-2-188.
PubMed 19946498Sheridan L, Lopez A, Perez A, John MM, Willis FB, Shanmugam R. Plantar fasciopathy treated with dynamic splinting: a randomized controlled trial. J Am Podiatr Med Assoc. 2010 May-Jun;100(3):161-5. doi: 10.7547/1000161.
PubMed 20479445Kalish SA, Willis FB. Hallux Limitus and Dynamic Splinting: a Retrospective Series. The Foot & Ankle Online Journal 2009 Apl;2(4),1
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Equinus Contracture Treated With Dynamic Splinting in a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01238484
- Acronym / sponsor ID
- 2010:004
- Conditions
- Ankle Equinus, Ankle Contracture, Diabetes Mellitus
- Keywords
- Ankle Equinus, Ankle contracture, Diabetes Mellitus, Dynasplint, AFD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Centers could not meet enrollment goals
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- McMurry University
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Nov 2010 (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.
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in treating contracture for patients with Ankle Equinus secondary to diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard of carePatients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises. |
| Experimental | Experimental | Device: DynasplintPatients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous Diagnosis Diabetes Mellitus
- Reduced flexibility in AROM of extension in the ankle
- Less than 10º Maximal, Active Dorsiflexion, while upright
- Impaired gait pattern
Key exclusion criteria (11 listed)
- Previous surgical treatment for this pathology
- Previous surgery of the Achilles tendon or triceps surae
- Current treatment with corticosteroids
- Current treatment with Botulinium Toxin-A (Botox), lower extremity
- Current treatment Fluoroquinolones (antibiotic medication)
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 |
|---|---|---|
| Standard of careshoe modification home stretching exercises | Other | Control |
| Dynasplintshoe modification home stretching exercises Ankle Dorsiflexion Dynasplint | Device | Experimental |
Primary outcome
Range of Motion
Time frame: 4 months
The primary outcome is change in ankle range of motion
1 secondary outcome
Pain
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Centers could not meet enrollment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- Background: PubMed 12379973Van Gils CC, Roeder B. The effect of ankle equinus upon the diabetic foot. Clin Podiatr Med Surg. 2002 Jul;19(3):391-409, vi. doi: 10.1016/s0891-8422(02)00010-1.
- Background: PubMed 12381796Lavery LA, Armstrong DG, Boulton AJ; Diabetex Research Group. Ankle equinus deformity and its relationship to high plantar pressure in a large population with diabetes mellitus. J Am Podiatr Med Assoc. 2002 Oct;92(9):479-82. doi: 10.7547/87507315-92-9-479.
- Background: PubMed 12647847Armstrong DG, Boulton AJ. Continuous Internet-based activity monitoring provides a surrogate marker for nocturnal polyuria in persons with diabetes mellitus at high risk for foot ulceration. Diabet Med. 2002 Dec;19(12):1034-5. doi: 10.1046/j.1464-5491.2002.00696_2.x. No abstract available.
- Background: PubMed 11021048Dananberg HJ, Shearstone J, Guillano M. Manipulation method for the treatment of ankle equinus. J Am Podiatr Med Assoc. 2000 Sep;90(8):385-9. doi: 10.7547/87507315-90-8-385.
- BackgroundLopez AA, Kalish SR, John MM, Willis FB. Reduction of Ankle Equinus Contracture Secondary to Diabetes Mellitus with Dynamic Splinting. Foot & Ankle Online Journal. 2010 3(3):13-18
- Background: PubMed 10693087Birke JA, Patout CA Jr, Foto JG. Factors associated with ulceration and amputation in the neuropathic foot. J Orthop Sports Phys Ther. 2000 Feb;30(2):91-7. doi: 10.2519/jospt.2000.30.2.91.
- Background: PubMed 16534718Wallny T, Brackmann H, Kraft C, Nicolay C, Pennekamp P. Achilles tendon lengthening for ankle equinus deformity in hemophiliacs: 23 patients followed for 1-24 years. Acta Orthop. 2006 Feb;77(1):164-8. doi: 10.1080/17453670610045867.
- Background: PubMed 1783755Grady JF, Saxena A. Effects of stretching the gastrocnemius muscle. J Foot Surg. 1991 Sep-Oct;30(5):465-9.
- Background: PubMed 17665354Bowers AL, Castro MD. The mechanics behind the image: foot and ankle pathology associated with gastrocnemius contracture. Semin Musculoskelet Radiol. 2007 Mar;11(1):83-90. doi: 10.1055/s-2007-984418.
- Background: PubMed 16476917Mullaney MJ, McHugh MP, Tyler TF, Nicholas SJ, Lee SJ. Weakness in end-range plantar flexion after Achilles tendon repair. Am J Sports Med. 2006 Jul;34(7):1120-5. doi: 10.1177/0363546505284186. Epub 2006 Feb 13.
- Background: PubMed 19857837Chen L, Greisberg J. Achilles lengthening procedures. Foot Ankle Clin. 2009 Dec;14(4):627-37. doi: 10.1016/j.fcl.2009.08.002.
- BackgroundLai J, Jones M, Willis B. Effect of Dynamic Splinting on Excessive Plantar Flexion Tone/Contracture: A Controlled, Cross-Over study. Proceedings of the 16th European Congress of Physical and Rehabilitation Medicine. Minerva Medica pubs, Italy, August 2008, pg 106-109.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynasplint in people with Ankle Equinus and Ankle Contracture, run by Dynasplint Systems, Inc. at 2 sites 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Centers could not meet enrollment goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01238484, which also lists 17 linked publications.
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 11 Jul 2013.