WithdrawnPhase 1

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

Stopped: No patients recruited.

0Started 2024-07-25

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria to select the participants (intervention and control): * 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 Exclusion criteria (intervention and control): * 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)

What they're measuring

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

Timeframe: Up to 8 weeks

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

Timeframe: Up to 8 weeks

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

Timeframe: Up to 8 weeks

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

Timeframe: Up to 8 weeks

Trial details

NCT IDNCT06493539

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Wound Heal trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 8 weeks

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

Timeframe: Up to 8 weeks

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

Timeframe: Up to 8 weeks

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

Timeframe: Up to 8 weeks