Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

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Smith & Nephew

Status

Completed

Conditions

Venous Leg Ulcers
Diabetic Foot Ulcers

Treatments

Device: PICO System
Device: tNPWT System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02470806
CE-052PIC

Details and patient eligibility

About

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.

Full description

The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.

Enrollment

164 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups

PICO System
Experimental group
Description:
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
Treatment:
Device: PICO System
tNPWT System
Active Comparator group
Description:
Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.
Treatment:
Device: tNPWT System

Trial documents
2

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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