Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System

NCT01623882 | Withdrawn DMC

• 1 other identifier: 041311
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes Mellitus; Wounds; Ulcers

Outcome Measures

Primary Outcomes (1)

• Percentage of wounds closed

  12 weeks

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 with lower extremity venous and diabetic ulcers.

You may qualify if:

• Wound \< 10 cm in greatest diameter
• Wound age \> 4 weeks and patient shows \< 50% wound area healing after 4 weeks of treatment
• Patient \> 18 years of age
• Patient is willing and able to sign consent
• Patient is willing and able to complete study visits and comply with study dressing protocols

You may not qualify if:

• Wound size reduction of \> 50% in last 4 weeks of treatment
• Patients with active wound infections, including cellulitis and osteomyelitis
• Patients with wounds not able to have eschar debrided
• ABI \< 0.65 or SPP \< 30mmHg
• Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
• Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc.
• Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial.
• Pregnant patients
• Patients unable to tolerate NPWT
• Patients with dialysis dependent ESRD
• Index ulcer is on the plantar surface of the foot

Sponsors & Collaborators

• KCI USA, Inc: lead
• Organogenesis: collaborator
• 3M: collaborator

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Wounds and Injuries; 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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Schubart, MD, PhD

  O'Connor Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 25, 2024

Record last verified: 2024-11