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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Foot Ulcer
Peripheral Neuropathy
Procedure: Achilles tendon-lengthening surgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 60
Study Start Date: August 1998
Estimated Study Completion Date: May 2003
Detailed Description:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006426

Locations
United States, Missouri
Barnes-Jewish Hospital, Orthopedic Surgery
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Investigators
Principal Investigator: Michael J. Mueller, Ph.D., P.T. Program in Physical Therapy, Washington University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006426     History of Changes
Other Study ID Numbers: NICHD-0109, 1R01 HD36802
Study First Received: November 1, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Foot ulcers
Diabetes
Peripheral neuropathy
Casting
Achilles Lengthening
Ambulatory surgery
Foot deformity

Additional relevant MeSH terms:
Diabetes Mellitus
Foot Ulcer
Peripheral Nervous System Diseases
Ulcer
Endocrine System Diseases
Foot Diseases
Glucose Metabolism Disorders
Leg Ulcer
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer

ClinicalTrials.gov processed this record on October 23, 2014