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Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers Clinical research trials and Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers. Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers clinical trial. Human subjects often get the best healthcare available for their Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers  Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers
Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers
For Condition: Foot Ulcer,Peripheral Neuropathy,Diabetes Mellitus
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the foot in a cast, to using a cast alone. The study will also examine how foot strength, joint movement, and overall ability to walk, balance and climb stairs is affected.
Details: Patients with diabetes mellitus (DM) and peripheral neuropathy are at high risk for forefoot plantar ulcers and subsequent lower extremity amputation. Total contact casting currently is the most effective treatment for healing neuropathic plantar ulcers but ulcer recurrence is high (30-50%) when patients discontinue casting and resume walking. An equinus deformity (limited ankle dorsiflexion range-of-motion) is associated with these recurrent ulcers. Although descriptive evidence indicates an Achilles lengthening procedure (which corrects the equinus deformity) can improve healing rates in these chronic ulcers, there have been no controlled studies. This randomized prospective controlled clinical trial will determine if percutaneous Achilles lengthening and total contact casting is more effective than total contact casting alone in healing forefoot plantar ulcers (n=30/group will allow detection of 25% effect with power of 0.8 at alpha level of 0.05). Secondary purposes are to determine the effects of casting and percutaneous lengthening on measures of impairments, functional limitations, and disability in patients with DM and peripheral neuropathy. The specific aims of this project are to determine the effect of the Achilles lengthening procedure on patients with DM, peripheral neuropathy, a forefoot ulcer, and an equinus deformity in regards to 1) Wound healing, 2) Impairments (dorsiflexion range-of-motion, plantar flexor muscle performance), 3) Functional Limitations (Physical Performance Test, Functional Reach, walking ability), and 4) Disability (SF36). The results will have important implications for prevention of wound infection and lower extremity amputation; and improvement in impairments, functional limitations, and disability in this group of high risk patients with chronic disease. Approximately 30 patients will be recruited for each of the treatment groups.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - History of Diabetes Mellitus - Limitation of dorsiflexion ankle range of motion to zero degrees or less - Recurrent or nonhealing ulcer (Grade II, Wagner scale) Exclusion Criteria: - Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure. - Patients with a history of CVA or other significant neurological problems complicating their rehabilitation. - Patients with a history of midfoot or hindfoot Charcot fractures. - Patients with an Ankle-Arm index < 0.45 or absolute toe pressure < 40 mm Hg. - Patients medically unfit for the anesthesia required for this Achilles lengthening procedure.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
MichaelMueller, Principal Investigator, Program in Physical Therapy, Washington University
Barnes-Jewish Hospital, Orthopedic Surgery
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: NICHD-0109; 1R01 HD36802
Study Start Date: August 1998
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006426
Other Peripheral Neuropathy Studies:
1. Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers
2. Painful HIV Neuropathy and Alpha-Lipoic Acid
3. A study of Rituxan in the treatment of polyneuropathies associated with serum IgM autoantibodies
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Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers
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