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

• ClinicalTrials.gov Identifier: NCT01770509
• Recruitment Status: Completed
• First Posted: January 17, 2013
• Results First Posted: January 11, 2017
• Last Update Posted: January 11, 2017
• Sponsor: M.D. Lederman Consulting Ltd
• Information provided by (Responsible Party): M.D. Lederman Consulting Ltd

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.

Condition or disease	Intervention/treatment	Phase
Ulcer; Venous Ulcer; Skin Ulcer; Leg Ulcer	Device: NMBM; Other: Compression garments	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: February 2013
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

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	Device: NMBM; Daily application of NMBM in addition to compression therapy; Other: Compression garments; Compression garments

Outcome Measures

Primary Outcome Measures :

1. Logarithm of Percentage of Baseline Ulcer Size [ Time Frame: From start of treatment to 4 weeks ]
   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 :

1. Alleviation of Pain [ Time Frame: 4 weeks ]
   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
2. Incidence of Adverse Events at 4 Weeks [ Time Frame: 4 weeks ]
   Number of patients with adverse effects at 4 weeks
3. Incidence of Adverse Events [ Time Frame: 4 weeks ]
   Number of adverse effects at 4 weeks
4. Time to Complete Closure [ Time Frame: 4 weeks ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Israel

The Department of Dermatology, Sheba Medical Center

Ramat-Gan, Israel, 52621

Sponsors and Collaborators

M.D. Lederman Consulting Ltd

Investigators

• Principal Investigator: Shoshana Greenberger, MD PhD; The Department of Dermatology, Sheba Medical Center

More Information

• Responsible Party: M.D. Lederman Consulting Ltd
• ClinicalTrials.gov Identifier: NCT01770509
• Other Study ID Numbers: SHEBA -11- 9204-SG-CTIL
• First Posted: January 17, 2013
• Results First Posted: January 11, 2017
• Last Update Posted: January 11, 2017
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by M.D. Lederman Consulting Ltd:

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

Additional relevant MeSH terms:

Varicose Ulcer; Leg Ulcer; Skin Ulcer; Ulcer; Pathologic Processes; Skin Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases