Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2012 |
| End Date: | December 2015 |
| Contact: | Peter Schubart, MD, PhD |
| Email: | schubart@ix.netcom.com |
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.
use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous
stasis lower extremity ulcers.
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
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