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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by M.D. Lederman Consulting Ltd
Sponsor:
Information provided by (Responsible Party):
M.D. Lederman Consulting Ltd
ClinicalTrials.gov Identifier:
NCT01770509
First received: January 13, 2013
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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
Ulcer
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
Other Name: 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
Other Name: Compression garments

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770509

Contacts
Contact: Shoshana Greenberger, MD PhD 972-3-5302443 Shoshana.Greenberger@sheba.health.gov.il

Locations
Israel
The Department of Dermatology, Sheba Medical Center Not yet recruiting
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

No publications provided

Responsible Party: M.D. Lederman Consulting Ltd
ClinicalTrials.gov 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
Ulcer
Varicose Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014