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Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers - Article


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Achilles tendon rupture

 




Clinical Trial: Achilles Tendon Lengthening in Patients with Diabetes to Prevent Foot Ulcers

This study has been completed.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

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 Treatment or Intervention Phase
Diabetes Mellitus
Foot Ulcer
Peripheral Neuropathy
 Procedure: Achilles tendon-lengthening surgery
Phase I

MedlinePlus related topics:  Diabetes;   Foot Injuries and Disorders;   Leg Injuries and Disorders;   Peripheral Nerve Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  60

Study start: August 1998;  Study completion: May 2003

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

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.

Location Information


Missouri
      Barnes-Jewish Hospital, Orthopedic Surgery, St. Louis,  Missouri,  63110,  United States

Study chairs or principal investigators

Michael J. Mueller, Ph.D., P.T.,  Principal Investigator,  Program in Physical Therapy, Washington University   

More Information

Washington University School of Medicine

For more information on the National Institute of Child Health and Human Development (NICHD).

Publications

Mueller MJ, Diamond JE, Sinacore DR, Delitto A, Blair VP 3rd, Drury DA, Rose SJ. Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial. Diabetes Care. 1989 Jun;12(6):384-8.

Mueller MJ, Sinacore DR, Hastings MK, Strube MJ, Johnson JE. Effect of Achilles Tendon Lengthening Procedure in People with Diabetes and a Neuropathic Plantar Ulcer: A Randomized Clinical Trial. In Press, JOURNAL OF BONE AND JOINT SURGERY. AM, 2003.

Hastings MK, Mueller MJ, Sinacore DR, Salsich GB, Engsberg JR, Johnson JE. Effects of a tendo-Achilles lengthening procedure on muscle function and gait characteristics in a patient with diabetes mellitus. J Orthop Sports Phys Ther. 2000 Feb;30(2):85-90.

Study ID Numbers:  NICHD-0109; 1R01 HD36802
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 2000
ClinicalTrials.gov Identifier:  NCT00006426
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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November 26, 2009



Page Updated: October 1, 2005
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