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

Primary Purpose

Chronic Wound

Status

Terminated

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

RPh201, botanical drug product

About this trial

This is an interventional treatment trial for Chronic Wound focused on measuring chronic wound, ulcerated wound, venous insufficiency, lymphatic insufficiency, neuropathic wound, diabetic ulcer, post- operative, post-traumatic chronic wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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

Sites / Locations

High Risk Foot Clinic - Maccabi Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Evaluation of the correlation between the treatment period and changes in wound area size. Assessment of wound closure state in terms of % Non-viable area, % granulation tissue appearance, Assessment of wound closure state in terms of time to wound closure. Assessment of pain based on a pain analog scale of 1-10.

Full Information

NCT ID

NCT01429519

First Posted

September 4, 2011

Last Updated

August 30, 2018

Sponsor

Regenera Pharma Ltd

Collaborators

TransCom Global Ltd. (CRO)

1. Study Identification

Unique Protocol Identification Number

NCT01429519

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Due to slow recruitment

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenera Pharma Ltd

Collaborators

TransCom Global Ltd. (CRO)

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Wound

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RPh201, botanical drug product

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

90 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eran Tamir, Dr.

Organizational Affiliation

High Risk Foot Clinic - Maccabi Health Services Tel Aviv

Official's Role

Principal Investigator

Facility Information:

Facility Name

High Risk Foot Clinic - Maccabi Health Services

City

Tel-Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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