Determination of the Pathophysicologic Collagen Changes in the Diabetic Achilles Tendon

NCT01382628 | Completed

• 1 other identifier: 2011-101
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcers; Equinus Deformity

Keywords

Diabetes; Ulcers; Equinus Deformity; Amputation; Achilles Tendon; Limb Loss

Outcome Measures

Primary Outcomes (1)

• Structural and metabolic changes

  Characterize the structural and metabolic changes in the diabetic Achilles tendon as related to limb loss.

  1 year

Secondary Outcomes (1)

• Relationship between collagen changes and system changes

  1 year

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Hospital Center for Wound Healing

Washington D.C., District of Columbia, 20007, United States

Location

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.

MeSH Terms

Conditions

Diabetic Foot; Equinus Deformity; Diabetes Mellitus; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul J. Kim, DPM

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept of Plastic Surgery Director of Research

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

US (1)