- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623882
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System (OG/SNaP)
July 29, 2022 updated by: 3M
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
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with lower extremity venous and diabetic ulcers.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of wounds closed
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Schubart, MD, PhD, O'Connor Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
June 19, 2012
First Posted (Estimate)
June 20, 2012
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 29, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 041311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
-
ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan