Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon
This is a pilot study examining tendon collagen, collagen cross-linking, and markers of tendon extracellular matrix metabolism in the Achilles tendon of diabetic patients with ulcerations and amputations of the lower extremity.
Diabetic Foot Ulcers
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon.|
- Structural and metabolic changes [ Time Frame: 1 year ] [ Designated as safety issue: No ]Characterize the structural and metabolic changes in the diabetic Achilles tendon as related to limb loss.
- Relationship between collagen changes and system changes [ Time Frame: 1 year ] [ Designated as safety issue: No ]Describe the relationship between collagen changes and system changes in the diabetic patient.
Biospecimen Retention: Samples Without DNA
A tissue sample (20mg) of the Achilles tendon will be collected at this time. This tissue will be preserved in a dry ice container and shipped to Midwestern University for processing by the sub-investigator (CC). The specimens will be labeled numerically with a predetermined subject number. No patient identifying information will be on these samples.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Preulcerative plantar foot lesion
An area on the plantar foot, usually at the location of a bony prominence, that presents with erythema, significant hyperkeratosis, or thin, shiny skin.
Plantar ulcer no history of amputation
Plantar ulceration without a history of amputation or require an amputation.
Plantar ulcer and digital amputation
Plantar ulceration who will be undergoing a digital amputation.
Plantar ulcer and transmet amputation
Plantar ulceration who will be undergoing a transmetatarsal amputation.
Plantar ulceration and choparts
Plantar ulceration who will be undergoing Chopart's or more proximal amputation.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382628
|Contact: Paul J. Kim, DPM||202-444-0469||Paul.firstname.lastname@example.org|
|Contact: John Steinberg, DPMemail@example.com|
|United States, District of Columbia|
|Georgetown University Hospital Center for Wound Healing||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Paul J. Kim, DPM 202-444-0469 firstname.lastname@example.org|
|Contact: Mallory W Nichols, BS 202-444-0283 Mallory.Nichols@gunet.georgetown.edu|
|Principal Investigator: Paul J. Kim, DPM|
|Sub-Investigator: John Steinberg, DPM|
|Sub-Investigator: Christopher Attinger, MD|
|Sub-Investigator: Chad Carroll, PhD|
|Principal Investigator:||Paul J. Kim, DPM||Georgetown University Hospital|