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

NCT ID: NCT01429519

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-12-31

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 (botanical extract) formulated as an oil solution administered topically three times per week during an overall treatment period of up to 4 weeks in patients with hard to heal wounds.
• Efficacy assessment of wound improvement following the use of RPh201 oil solution (botanical extract) administered topically three times per week during an overall treatment period of up to 4 weeks and at the follow-up visit at 3 months after end of treatment in patients with hard to heal wounds

Conditions

Chronic Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

RPh201, botanical drug product

Intervention Type: 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

Interventions

RPh201, botanical drug product

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants, either men or women are ≥ 18 years of age.

2. 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.

3. The wound is refractive to healing at least 4 weeks prior to treatment, although treated by routine practice.

4. Wound area size is in the range of: 3 - 36 square centimeters.

5. Patients defined as grade C or above on the granulometer scale (see section 6.5.1).

6. Participants understand the nature of the procedure and provide written informed consent prior to any study procedure.

7. Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria

1. 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.

2. Clinical evidence for presence of infection in the soft tissue, joint and/or bone (osteomyelitis).

3. Wound has Non-viable tissue which covers more than 50% of the wound area.

4. Patients with skin disorders unrelated to the ulcer that are presented adjacent to the wound.

5. The wound penetrates into deep organs and involves bone, tendon or joint

6. Wound with sinus tracts

7. 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.

8. Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.

9. Patients that have a history of alcohol or drug abuse within the last two years.

10. Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.

11. Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.

12. Clinically significant and/or uncontrolled condition or other significant medical disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TransCom Global Ltd. (CRO)

UNKNOWN

Sponsor Role: collaborator

Regenera Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eran Tamir, Dr.

Role: PRINCIPAL_INVESTIGATOR

High Risk Foot Clinic - Maccabi Health Services Tel Aviv

Locations

High Risk Foot Clinic - Maccabi Health Services

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

RGN-WH-001

Identifier Type: -

Identifier Source: org_study_id