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Centers could not meet enrollment goals
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| Name | Class |
|---|---|
| McMurry University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Patients in the control group will be treated with the current standard of care including shoe modification and home stretching exercises. |
|
| Experimental | Experimental | Patients assigned to the experimental group will receive the current standard of care as well as the Ankle Dorsiflexion Dynasplint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | shoe modification home stretching exercises |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion | The primary outcome is change in ankle range of motion | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | The secondary outcome will be change in pain scale rating as reported by patient | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Foot and Leg Clinic | Jonesboro | Georgia | 30236 | United States | ||
| Lopez Ankle and Foot |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12379973 | Background | 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. | |
| 12381796 | Background | Lavery 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Dynasplint |
| Device |
shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint |
|
| Fort Worth |
| Texas |
| 76164 |
| United States |
| 12647847 | Background | Armstrong 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. |
| 11021048 | Background | Dananberg 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. |
| Background | Lopez 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 |
| 10693087 | Background | 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. |
| 16534718 | Background | Wallny 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. |
| 1783755 | Background | Grady JF, Saxena A. Effects of stretching the gastrocnemius muscle. J Foot Surg. 1991 Sep-Oct;30(5):465-9. |
| 17665354 | Background | Bowers 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. |
| 16476917 | Background | Mullaney 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. |
| 19857837 | Background | Chen L, Greisberg J. Achilles lengthening procedures. Foot Ankle Clin. 2009 Dec;14(4):627-37. doi: 10.1016/j.fcl.2009.08.002. |
| Background | Lai 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. |
| 19946498 | Background | 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. |
| 20479445 | Background | Sheridan 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. |
| Background | Kalish SA, Willis FB. Hallux Limitus and Dynamic Splinting: a Retrospective Series. The Foot & Ankle Online Journal 2009 Apl;2(4),1 |
| 19940225 | Background | Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. doi: 10.2337/dc09-0459. |
| 19411496 | Background | Kooistra B, Dijkman B, Einhorn TA, Bhandari M. How to design a good case series. J Bone Joint Surg Am. 2009 May;91 Suppl 3:21-6. doi: 10.2106/JBJS.H.01573. |