Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers

NCT ID: NCT00006426

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2003-05-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus; Foot Ulcer; Peripheral Neuropathy

Keywords

Foot ulcers; Diabetes; Peripheral neuropathy; Casting; Achilles Lengthening; Ambulatory surgery; Foot deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Achilles tendon-lengthening surgery

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 0 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Principal Investigators

Michael J. Mueller, Ph.D., P.T.

Role: PRINCIPAL_INVESTIGATOR

Program in Physical Therapy, Washington University

Locations

Barnes-Jewish Hospital, Orthopedic Surgery

St Louis, Missouri, United States

Countries

United States

References

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. doi: 10.2337/diacare.12.6.384.

Reference Type: BACKGROUND

PMID: 2659299 (View on PubMed)

Mueller MJ, Sinacore DR, Hastings MK, Strube MJ, Johnson JE. Effect of Achilles tendon lengthening on neuropathic plantar ulcers. A randomized clinical trial. J Bone Joint Surg Am. 2003 Aug;85(8):1436-45.

Reference Type: BACKGROUND

PMID: 12925622 (View on PubMed)

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. doi: 10.2519/jospt.2000.30.2.85.

Reference Type: BACKGROUND

PMID: 10693086 (View on PubMed)

Related Links

http://medschool.wustl.edu

Washington University School of Medicine

http://www.nichd.nih.gov/

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

Other Identifiers

1R01HD036802

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NICHD-0109

Identifier Type: -

Identifier Source: org_study_id