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

Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01770509
• Other study ID #: SHEBA -11- 9204-SG-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 13, 2013
• Last updated: January 15, 2013
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2013
• Source: M.D. Lederman Consulting Ltd
• Contact: Shoshana Greenberger, MD PhD
• Phone: 972-3-5302443
• Email: Shoshana.Greenberger[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Skin Ulcer
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Device:
• NMBM
Daily application of NMBM in addition to compression therapy

Other:
• Compression garments
Compression garments

Locations

Country	Name	City	State
Israel	The Department of Dermatology, Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Lederman Consulting Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of change from baseline in the target wound area	Relative change (in percents) of ulcer size perimeter(longest wound length x longest width) from baseline to 4 weeks	From start of treatment to 4 weeks	No
Secondary	Alleviation of pain	Change in pain, assessed by the patient on a VAS scale from 0 to 10, between baseline and 4 weeks	4 weeks	No
Secondary	Incidence of adverse events		2 weeks	Yes
Secondary	Incidence of adverse events		4 weeks	Yes
Secondary	Time to complete closure		4 weeks	No