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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 October 2012
• Main ID: NCT01429519
• Date of registration: 04/09/2011
• Primary sponsor: Regenera Pharma Ltd
• Public title: Efficacy of RPh201 Applied Topically for the Treatment of Hard to Heal Chronic Ulcerated Wounds
• Scientific title: A PRELIMINARY OPEN CLINICAL STUDY, TO ASSESS THE SAFETY AND EFFICACY OF RPh201 APPLIED TOPICALLY FOR THE TREATMENT OF HARD TO HEAL CHRONIC ULCERATED WOUNDS
• Date of first enrolment: December 2011
• Target sample size: 15
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01429519
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Israel

Contacts

• Name: Eran Tamir, Dr.
• Affiliation: High Risk Foot Clinic - Maccabi Health Services Tel Aviv

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Wound

Intervention(s)

Drug: RPh201, botanical drug product

Primary Outcome(s)

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 [Time Frame: 90 days]

Secondary Outcome(s)

To obtain preliminary data on the efficacy of RPh201 on improving wound status in patients with hard to heal chronic ulcerated wounds [Time Frame: 90 days]

Secondary ID(s)

RGN-WH-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

TransCom Global Ltd. (CRO)