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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcer; Leg Ulcer; Skin Ulcer; Venous Ulcer
• Intervention / Treatment: Other: Compression garments; Device: NMBM

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Ramat-Gan, Israel, 52621
    • The Department of Dermatology, Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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;
2. Male or female subjects, ≥18 to ≤90 years of age
3. Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
4. Chronic venous insufficiency or post-erysipelas ulcer
5. Ulcer size between 5 and 170 sq cm, inclusive
6. Ulcer present for at least one month
7. ankle-brachial index >0.7

Exclusion Criteria:

1. Suffers from diabetes mellitus with HbA1c ≥ 8%
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Standard of care: Dressings +Compression garments	Other: Compression garments; Compression garments
Experimental: Application of NMBM; Daily application of NMBM	Other: Compression garments; Compression garments; Device: NMBM; Daily application of NMBM in addition to compression therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From start of treatment to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks
Incidence of Adverse Events at 4 Weeks	Number of patients with adverse effects at 4 weeks	4 weeks
Incidence of Adverse Events	Number of adverse effects at 4 weeks	4 weeks
Time to Complete Closure		4 weeks

Collaborators and Investigators

• Sponsor: M.D. Lederman Consulting Ltd
• Investigators: Principal Investigator: Shoshana Greenberger, MD PhD, The Department of Dermatology, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 13, 2013
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (Estimate): January 17, 2013

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Chronic venous leg ulcers; Venous ulcer; Stasis ulcer; Varicose ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Skin Ulcer
• Other Study ID Numbers: SHEBA -11- 9204-SG-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided