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

NCT06493539 | Withdrawn Phase 1

• 1 other identifier: APP-22-00260 USC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (4)

• Number of participants with reduction of edema as assessed using Girth measurements and Grading system.

  Measurement of edema reduction using the +1 to +4 grading system as well as girth measurements of lower extremity of using measuring tape.

  Up to 8 weeks

• Number of participants with Greater acceptability, tolerability and convenience as assessed by Short Form 36 and patient provided feedback.

  Determine the overall tolerability, acceptability, and convenience of the intervention using Patient surveys and patient provided feedback.

  Up to 8 weeks

• Number of participants with shorter time to ambulation and weight-bearing as measured by a stopwatch.

  CiNPWT effect on ambulation by measuring time to ambulation, time to weight-bearing as measured by a stopwatch.

  Up to 8 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".

  CiNPWT on number of needed physical therapy visits, adverse events, surgical site infection, re-amputation/revision rate, dehiscence, dressing failure, unscheduled/emergency encounters, hospital-acquired pressure injuries.

  Up to 8 weeks

Study Arms (2)

Control group: Standard of Care

ACTIVE COMPARATOR

Following amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily.

Procedure: Standard of Care group

CiNPWT treatment group

EXPERIMENTAL

Following amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as \~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days. A patient may always be removed from treatment intervention whenever they wish.

Device: CINPWT

Interventions

Standard of Care group PROCEDURE

The control group will receive standard of care wound treatment

Control group: Standard of Care

CINPWT DEVICE

Subject will receive CINPWT until discharged

CiNPWT treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual aged 18 years or older
• Individual with a closed incision following LEA (transmetatarsal or proximal)
• Individual presents with adequate perfusion based on WIfI ischemia component score of less than 2 (\>30mm Hg TCPO2 or higher at region of amputation)
• Individual presents with no residual surgical site infection (WIfI grade 0) post LEA
• Individual is competent to make their own medical decisions

You may not qualify if:

• Individual presents with any defined contraindications to NPWT (e.g., allergy).
• Individual presents with residual acute osteomyelitis (after amputation).
• Individual with collagen vascular disease or malignant disease in the wound
• Individual has uncontrolled hyperglycemia (glycosylated hemoglobin \[HbA1c\]\>12%).
• Individual is currently taking corticosteroids, immunosuppressive drugs, or chemotherapy and is not on stable course of therapy as determined by principal investigator
• Individual has a history of local radiation therapy that could impact the edema of the amputated limb.
• Individual has pre-existing conditions contributing to residual limb edema (i.e., nephropathy, congestive heart failure, primary lymphedema, etc.).
• Withdrawal of individuals:
• Voluntary withdrawal
• Death
• Lost to follow-up
• Termination of compression therapy (control or intervention group)

Sponsors & Collaborators

• University of Southern California: lead
• 3M: collaborator

Related Publications (24)

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  PMID: 33761757 RESULT

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  PMID: 31536201 RESULT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. David Armstrong DPM, MD, PhD, Principal Investigator

Model Details: Intervention Following amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as \~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days. A patient may always be removed from treatment intervention whenever they wish. Control Following amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: July 10, 2024
• Study Start: July 25, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share