Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds

NCT01429519 | Terminated Phase 1

• 1 other identifier: RGN-WH-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wound

Keywords

chronic wound; ulcerated wound; venous insufficiency; lymphatic insufficiency; neuropathic wound; diabetic ulcer; post- operative; post-traumatic chronic wound

Outcome Measures

Primary Outcomes (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

  * Safety evaluation - To demonstrate safety using the RPh201 oil solution in terms of skin irritation score to be less than 2 for erythema /edema individual subject's results or less then 1.9 for Primary Irritation Index (PII) category (see section 6.5.2 and APPENDIX 2) . * Safety evaluation - To demonstrate safety of using RPh201 oil solution in terms of type and severity of adverse events.

  90 days

Secondary Outcomes (1)

• To obtain preliminary data on the efficacy of RPh201 on improving wound status in patients with hard to heal chronic ulcerated wounds

  90 days

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: RPh201, botanical drug product

Interventions

RPh201, botanical drug product DRUG

topical, three times per week for a period of 4 consecutive weeks, followed by a single follow up visit 3 months post end of the last treatment day

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenera Pharma Ltd: lead
• TransCom Global Ltd. (CRO): collaborator

Study Sites (1)

High Risk Foot Clinic - Maccabi Health Services

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eran Tamir, Dr.

  High Risk Foot Clinic - Maccabi Health Services Tel Aviv

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2011
• First Posted: September 7, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

IL (1)