Status:
TERMINATED
Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
Lead Sponsor:
Regenera Pharma Ltd
Collaborating Sponsors:
TransCom Global Ltd. (CRO)
Conditions:
Chronic Wound
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
The study objectives are to evaluate safety and efficacy, of topical administration of RPh201 for treatment of patients with hard to heal wounds. This is to include: * Safety evaluation of RPh201 (b...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients that have a history of alcohol or drug abuse within the last two years.
- Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
- Clinically significant and/or uncontrolled condition or other significant medical disease
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01429519
Start Date
December 1 2011
End Date
December 1 2012
Last Update
September 4 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
High Risk Foot Clinic - Maccabi Health Services
Tel Aviv, Israel