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Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon

This study is currently recruiting participants.
Verified March 2013 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
Paul J. Kim, DPM, Georgetown University
ClinicalTrials.gov Identifier:
NCT01382628
First received: June 21, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preulcerative plantar foot lesion
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382628

Contacts
Contact: Paul J. Kim, DPM 202-444-0469 Paul.j.kim@gunet.georgetown.edu
Contact: John Steinberg, DPM 202-444-3059 john.s.steinberg@gunet.georgetown.edu

Locations
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     paul.j.kim@gunet.georgetown.edu    
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            
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Paul J. Kim, DPM Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Paul J. Kim, DPM, Associate Professor, Dept of Plastic Surgery Director of Research, Georgetown University
ClinicalTrials.gov Identifier: NCT01382628     History of Changes
Other Study ID Numbers: 2011-101
Study First Received: June 21, 2011
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Congenital Abnormalities
Equinus Deformity
Clubfoot
Ulcer
Foot Ulcer
Diabetic Foot
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Pathologic Processes
 Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 16, 2013