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CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)

NCT06493539 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-01-16

No results posted yet for this study

Summary

The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression wrapping and wound care post-LEA.

This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).

Conditions

  • Wound Heal
  • Wound Dehiscence

Interventions

PROCEDURE

Standard of Care group

The control group will receive standard of care wound treatment

DEVICE

CINPWT

Subject will receive CINPWT until discharged

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2025-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06493539 on ClinicalTrials.gov