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 range18 Years
SexALL
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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.
✓. 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.
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
. 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.