Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006426
First received: November 1, 2000
Last updated: June 23, 2005
Last verified: March 2003

November 1, 2000
June 23, 2005
August 1998
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Complete list of historical versions of study NCT00006426 on ClinicalTrials.gov Archive Site
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Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers
Controlled Clinical Trial Comparing the Effect of an Achilles Tendon Lengthening Procedure and Casting to Casting Alone for the Treatment of Neuropathic Forefoot Plantar Ulcers in Patients With Diabetes Mellitus

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Foot Ulcer
  • Peripheral Neuropathy
Procedure: Achilles tendon-lengthening surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2003
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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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006426
NICHD-0109, 1R01 HD36802
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Michael J. Mueller, Ph.D., P.T. Program in Physical Therapy, Washington University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP