Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care (NCT02138994) | Clinical Trial Compass
CompletedNot Applicable
Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
United States43 participantsStarted 2014-07
Plain-language summary
This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.
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 female 18 years or older
* Presence of full-thickness wound for more than one month (i.e. chronic)
* Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
* NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
* Willing to comply with all study procedures and be available for the duration of the study
* Provide signed and dated informed consent
Exclusion Criteria:
* Subjects unable to provide signed and dated informed consent
* Male or female less than 18 years old
* Presence of a full-thickness wound for less than one month
* A candidate for vascular reconstructive surgery to restore blood flow to the wound
* Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
* Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
* Subject with known allergic reaction to the study products
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.