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NCT01623882 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

— OG/SNaP  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01623882
Other study ID # 041311
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2012
Est. completion date December 2015

Study information
Verified date July 2022
Source 3M
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
3M Organogenesis

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of wounds closed 12 weeks
See also
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