Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Foot Ulcer, Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT00006426

Run by

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

People needed

60

Starts

1998-08-01

Expected to finish

2003-05-01

Last updated by the study team

2005-06-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Barnes-Jewish Hospital, Orthopedic Surgery — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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