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Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon

This study has suspended participant recruitment.
(We are currently trying to find someone to assay the collagen)
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University Identifier:
First received: June 21, 2011
Last updated: November 8, 2016
Last verified: November 2016
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
Equinus Deformity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon.

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Structural and metabolic changes [ Time Frame: 1 year ]
    Characterize the structural and metabolic changes in the diabetic Achilles tendon as related to limb loss.

Secondary Outcome Measures:
  • Relationship between collagen changes and system changes [ Time Frame: 1 year ]
    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.

Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Georgetown University Hospital, Center for Wound Healing or patients admitted to the Georgetown University Hospital (where the Limb service has been designated as a consulting or primary service) will be recruited into the study. Patients scheduled for an Achilles tendon lengthening procedure (as part of their SOC) will be recruited.

Inclusion Criteria:

  • Type I or Type II Diabetes - diagnosed by their primary care provider
  • Demonstrates an equinus ankle deformity - Less than 0 degrees of passive dorsiflexion at the ankle joint with the knee extended or flexed.
  • Preulcerative plantar foot lesions - In the form of a callus with the epithelium intact

OR may also have the following:

  • Plantar ulceration without a history of amputations
  • Plantar ulceration with a history of digital amputations - or planned digital amputation
  • Plantar ulceration with a history of transmetatarsal amputations - or planned transmetatarsal amputation
  • Plantar ulceration with a history of Chopart's or more proximal amputation - or planned Chopart's or more proximal amputation

Exclusion Criteria:

  • Does not demonstrate an equinus ankle deformity
  • Cannot undergo elective surgery for any reason
  • History of Achilles tendon lengthening procedure performed
  • History of traumatic (acute or chronic) injury to the Achilles tendon
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01382628

United States, District of Columbia
Georgetown University Hospital Center for Wound Healing
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: Paul J. Kim, DPM Georgetown University Hospital
  More Information

Responsible Party: Paul J. Kim, DPM, Associate Professor, Dept of Plastic Surgery Director of Research, Georgetown University Identifier: NCT01382628     History of Changes
Other Study ID Numbers: 2011-101
Study First Received: June 21, 2011
Last Updated: November 8, 2016

Keywords provided by Georgetown University:
Equinus Deformity
Achilles Tendon
Limb Loss

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Congenital Abnormalities
Equinus Deformity
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities processed this record on May 22, 2017