Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds (NCT01429519) | Clinical Trial Compass
TerminatedPhase 1/2
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
Stopped: Due to slow recruitment
Israel4 participantsStarted 2011-12
Plain-language summary
The study objectives are to evaluate safety and efficacy of topical administration of RPh201 oil solution (botanical extract) for treatment of patients with hard to heal chronic ulcerated wounds.
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
. Participants, either men or women are ≥ 18 years of age.
. Patients must have at least one hard to heal wound of different etiologies (venous insufficiency, lymphatic insufficiency, neuropathic wounds or diabetic ulcers, post- operative and post-traumatic chronic wounds) located on the leg shin or foot.
. The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.
. Wound area size is in the range of: 3 - 36 square centimeters.
. Patients defined as grade C or above on the granulometer scale (see section 6.5.1).
. Participants understand the nature of the procedure and provide written informed consent prior to any study procedure.
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
To determine the safety use of RPh201 administered topically three times a week during an overall treatment period of up to 4 weeks, with 52 days follow-up
. Women of child bearing potential must use adequate birth-control precautions.
Exclusion criteria
. Clinically significant arterial vascular disease with ABI index \<0.45 if the peripheral pulse is not palpable, or flatted PVR in case of non palpable arteries.
. Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).
. Wound has Non-viable tissue which covers more than 50% of the wound area.
. Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.
. The wound penetrates into deep organs and involves bone, tendon or joint
. Wound with sinus tracts
. Patients are receiving, or have received within one month prior to enrollment any treatment known to impair wound healing, including but not limited to: immuno-suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
. Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.