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Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System (OG/SNaP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01623882
Recruitment Status : Withdrawn (The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.)
First Posted : June 20, 2012
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
Organogenesis
Information provided by (Responsible Party):
KCI USA, Inc.

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.

Condition or disease
Diabetic Foot Ulcer

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers
Actual Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of wounds closed [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lower extremity venous and diabetic ulcers.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623882


Sponsors and Collaborators
KCI USA, Inc.
Organogenesis
Investigators
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Principal Investigator: Peter Schubart, MD, PhD O'Connor Hospital
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01623882    
Other Study ID Numbers: 041311
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Keywords provided by KCI USA, Inc.:
Diabetes Mellitus
Wounds
Ulcers
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases