N/A
N=164
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
Venous Leg Ulcers · Diabetic Foot Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02470806 ↗Enrolled (actual)
164
Serious AEs
8.5%
Results posted
Apr 2020
Primary outcome: Primary: Change in Ulcer Area From Baseline to the End of the Treatment Period — 6.2; 7.8; 0.7; 3.8 cm^2 — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PICO System (Device); tNPWT System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ulcer Area From Baseline to the End of the Treatment Period |
6.2; 7.8; 0.7; 3.8; -5.5; -4.0 | 0.001 sig |
| PRIMARY Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period |
-88.7; -58.6 | — |
| SECONDARY Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period |
4.0; 2.4; 0.6; 1.5; -3.4; -0.9 | — |
| SECONDARY Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period |
0.3; 0.3; 0.2; 0.1; -0.3; 0 | — |
| SECONDARY Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period |
-68.8; -38.8; -98.0; -10.1 | — |
Summary
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
Eligibility Criteria
INCLUSION CRITERIA
- Provide informed consent
- Age ≥ 18 years and of either sex
- Willing to comply with protocol instructions, including allowing all study assessments
- Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
- Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
- Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2
- Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
- Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
- Acceptable state of health and nutrition
EXCLUSION CRITERIA
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
- Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
- Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
- Clinical evidence of target ulcer infection
- Current systemic therapy with cytotoxic drugs.
- Current therapy with chronic (> 10 days) oral corticosteroids.
- Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
- Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Data sourced from ClinicalTrials.gov (NCT02470806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.