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The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study

Primary Purpose

Ulcer, Venous Ulcer, Skin Ulcer

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

NMBM

Compression garments

About this trial

This is an interventional treatment trial for Ulcer focused on measuring Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed and dated written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent obtained from the subject in accordance with the local regulations;
Male or female subjects, ≥18 to ≤90 years of age
Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
Chronic venous insufficiency or post-erysipelas ulcer
Ulcer size between 5 and 170 sq cm, inclusive
Ulcer present for at least one month
ankle-brachial index >0.7

Exclusion Criteria:

Suffers from diabetes mellitus with HbA1c ≥ 8%
Albumin less than

2. 2. Patients with the following abnormal laboratory test levels hemoglobin <10.5 g/dL platelet count <100 x 109/L serum albumin level < 2.5 g/dL 3. Suffers from clinically significant arterial disease 34. Has a known allergy to any of the compounds that are part of this protocol 45. Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone 56. Has used any investigational drug(s) within 30 days preceding randomization 67. Is unable to manage self-treatment 78. Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) 8. 9. Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data 9. 10. Unwilling or unable to comply with study requirements.

Sites / Locations

The Department of Dermatology, Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Application of NMBM

Arm Description

Standard of care: Dressings +Compression garments

Daily application of NMBM

Outcomes

Primary Outcome Measures

Logarithm of Percentage of Baseline Ulcer Size

Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width

Secondary Outcome Measures

Alleviation of Pain

Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain

Incidence of Adverse Events at 4 Weeks

Number of patients with adverse effects at 4 weeks

Incidence of Adverse Events

Number of adverse effects at 4 weeks

Time to Complete Closure

Full Information

NCT ID

NCT01770509

First Posted

January 13, 2013

Last Updated

November 14, 2016

Sponsor

M.D. Lederman Consulting Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01770509

Brief Title

The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study

Official Title

A Randomized, Parallel Group, Controlled Study to Assess the Efficacy and Safety of NMBM in the Treatment of Subjects With a Post-cellulitis and Venous Leg Ulcer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Lederman Consulting Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are common in patients older than 65 years and cause a significant morbidity. Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

Detailed Description

Ulcers of the lower extremities, particularly in patients older than 65 years, are common among the population. Studies estimate the prevalence of current chronic leg ulcers at approximately 1%. The most common cause (approximately 80%) is thought to be chronic venous insufficiency disease. Recurrent cellulitis is an additional common cause. The ulcers cause a significant morbidity and negative impact on the patients' quality of life. The care of chronic vascular ulcers places a significant burden on the patient and the health care system. Additionally, these nonhealing ulcers place the patient at much higher risk for lower extremity amputation. Natural Matrix Bio polymer Membrane (NMBM) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. The aim of this study is to test whether of Natural Matrix Bio polymer Membrane (NMBM) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

6. Conditions and Keywords

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

Ulcer, Venous Ulcer, Skin Ulcer, Leg Ulcer

Keywords

Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Standard of care: Dressings +Compression garments

Arm Title

Application of NMBM

Arm Type

Experimental

Arm Description

Daily application of NMBM

Intervention Type

Device

Intervention Name(s)

NMBM

Intervention Description

Daily application of NMBM in addition to compression therapy

Intervention Type

Other

Intervention Name(s)

Compression garments

Intervention Description

Compression garments

Primary Outcome Measure Information:

Title

Logarithm of Percentage of Baseline Ulcer Size

Description

Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width

Time Frame

From start of treatment to 4 weeks

Secondary Outcome Measure Information:

Title

Alleviation of Pain

Description

Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain

Time Frame

4 weeks

Title

Incidence of Adverse Events at 4 Weeks

Description

Number of patients with adverse effects at 4 weeks

Time Frame

4 weeks

Title

Incidence of Adverse Events

Description

Number of adverse effects at 4 weeks

Time Frame

4 weeks

Title

Time to Complete Closure

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed and dated written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent obtained from the subject in accordance with the local regulations; Male or female subjects, ≥18 to ≤90 years of age Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) Chronic venous insufficiency or post-erysipelas ulcer Ulcer size between 5 and 170 sq cm, inclusive Ulcer present for at least one month ankle-brachial index >0.7 Exclusion Criteria: Suffers from diabetes mellitus with HbA1c ≥ 8% Albumin less than 2. 2. Patients with the following abnormal laboratory test levels hemoglobin <10.5 g/dL platelet count <100 x 109/L serum albumin level < 2.5 g/dL 3. Suffers from clinically significant arterial disease 34. Has a known allergy to any of the compounds that are part of this protocol 45. Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone 56. Has used any investigational drug(s) within 30 days preceding randomization 67. Is unable to manage self-treatment 78. Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) 8. 9. Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data 9. 10. Unwilling or unable to comply with study requirements.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shoshana Greenberger, MD PhD

Organizational Affiliation

The Department of Dermatology, Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Department of Dermatology, Sheba Medical Center

City

Ramat-Gan

ZIP/Postal Code

52621

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study

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