Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Woun… (NCT04053946) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
Stopped: Site backed out
0Started 2019-10-01
Plain-language summary
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of 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
. Male or non-pregnant female 18 years or older
. Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure.
. There must be no infection present at the surgical incision site
. Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
. Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow
. No known allergic reaction or sensitivity to investigational product or components
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
Percentage of Incisional Wound Area Change
Timeframe: 28 Days
2
Time to when Patient is Ready for Prosthetic Fitting
. Willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study
. Provide signed and dated informed consent
Exclusion criteria
. Male or Female less than 18 years old
. Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period)
. Systemic sepsis at the time of surgery
. Disseminated Cancer Patients
. Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids
. Current long-term (more than 30 consecutive days) use of immune modulators/suppressors
. Known sensitivity to investigational product or any components
. Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states