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

NCT01770509 | Completed Phase 1 Results

• 1 other identifier: SHEBA -11- 9204-SG-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer; Venous Ulcer; Skin Ulcer; Leg Ulcer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Alleviation of Pain

  4 weeks

• Incidence of Adverse Events at 4 Weeks

  4 weeks

• Incidence of Adverse Events

  4 weeks

• Time to Complete Closure

  4 weeks

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Standard of care: Dressings +Compression garments

Other: Compression garments

Application of NMBM

EXPERIMENTAL

Daily application of NMBM

Device: NMBM; Other: Compression garments

Interventions

NMBM DEVICE

Daily application of NMBM in addition to compression therapy

Application of NMBM

Compression garments OTHER

Compression garments

Application of NMBM; Standard of care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Suffers from diabetes mellitus with HbA1c ≥ 8%
• Albumin less than
• \. 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.

Sponsors & Collaborators

• M.D. Lederman Consulting Ltd: lead

Study Sites (1)

The Department of Dermatology, Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Ulcer; Varicose Ulcer; Skin Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Shoshana Greenberger
• Organization: The Department of Dermatology, Sheba Medical Center

shoshana.greenberger@sheba.health.gov.il

972-3-5302443

Study Officials

• Shoshana Greenberger, MD PhD

  The Department of Dermatology, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2013
• First Posted: January 17, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 11, 2017
• Results First Posted: January 11, 2017

Record last verified: 2016-06

Locations

IL (1)