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 range
18 Years
Sex
ALL
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with reduction of edema as assessed using Girth measurements and Grading system.
Timeframe: Up to 8 weeks
2
Number of participants with Greater acceptability, tolerability and convenience as assessed by Short Form 36 and patient provided feedback.
Timeframe: Up to 8 weeks
3
Number of participants with shorter time to ambulation and weight-bearing as measured by a stopwatch.
Timeframe: Up to 8 weeks
4
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".