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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01623882

Acronym

OG/SNaP

Enrollment

Registered

2012-06-20

Start date

2012-06-30

Completion date

2015-12-31

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes Mellitus, Wounds, Ulcers

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of wounds closed	12 weeks

Outcome results