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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by M.D. Lederman Consulting Ltd.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
M.D. Lederman Consulting Ltd Identifier:
First received: January 13, 2013
Last updated: January 15, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Venous Ulcer
Skin Ulcer
Leg Ulcer
Device: NMBM
Other: Compression garments
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by M.D. Lederman Consulting Ltd:

Primary Outcome Measures:
  • Percent of change from baseline in the target wound area [ Time Frame: From start of treatment to 4 weeks ] [ Designated as safety issue: No ]
    Relative change (in percents) of ulcer size perimeter(longest wound length x longest width) from baseline to 4 weeks

Secondary Outcome Measures:
  • Alleviation of pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change in pain, assessed by the patient on a VAS scale from 0 to 10, between baseline and 4 weeks

  • Incidence of adverse events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Time to complete closure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01770509

The Department of Dermatology, Sheba Medical Center
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
M.D. Lederman Consulting Ltd
Principal Investigator: Shoshana Greenberger, MD PhD The Department of Dermatology, Sheba Medical Center
  More Information

Responsible Party: M.D. Lederman Consulting Ltd Identifier: NCT01770509     History of Changes
Other Study ID Numbers: SHEBA -11- 9204-SG-CTIL 
Study First Received: January 13, 2013
Last Updated: January 15, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by M.D. Lederman Consulting Ltd:
Chronic venous leg ulcers
Venous ulcer
Stasis ulcer
Varicose ulcer

Additional relevant MeSH terms:
Leg Ulcer
Skin Ulcer
Varicose Ulcer
Pathologic Processes
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases processed this record on December 09, 2016