Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006426
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-11-01
Brief Title:
Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n30group will allow detection of 25 effect with power of 08 at alpha level of 005 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
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 n30group will allow detection of 25 effect with power of 08 at alpha level of 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD036802 | NIH | None | httpsreporternihgovquickSearch1R01HD036802 |