Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers

NCT00006426 | Completed Phase 1

• 2 other identifiers: NICHD-01091R01HD036802
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Foot Ulcer; Peripheral Neuropathy

Keywords

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

Interventions

Achilles tendon-lengthening surgery PROCEDURE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• History of Diabetes Mellitus
• Limitation of dorsiflexion ankle range of motion to zero degrees or less
• Recurrent or nonhealing ulcer (Grade II, Wagner scale)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Barnes-Jewish Hospital, Orthopedic Surgery

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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.

  PMID: 2659299 BACKGROUND

• 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.

  PMID: 12925622 BACKGROUND

• 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.

  PMID: 10693086 BACKGROUND

Related Links

• Washington University School of Medicine
• For more information on the National Institute of Child Health and Human Development (NICHD).

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer; Peripheral Nervous System Diseases; Foot Deformities

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases

Study Officials

• Michael J. Mueller, Ph.D., P.T.

  Program in Physical Therapy, Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 1, 2000
• First Posted: November 2, 2000
• Study Start: August 1, 1998
• Study Completion: May 1, 2003
• Last Updated: June 24, 2005

Record last verified: 2003-03

Locations

US (1)