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

NCT ID: NCT01770509

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-02-28

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.

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.

Conditions

Ulcer; Venous Ulcer; Skin Ulcer; Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Standard of care: Dressings +Compression garments

Group Type: ACTIVE_COMPARATOR

Compression garments

Intervention Type: OTHER

Compression garments

Application of NMBM

Daily application of NMBM

Group Type: EXPERIMENTAL

NMBM

Intervention Type: DEVICE

Daily application of NMBM in addition to compression therapy

Compression garments

Intervention Type: OTHER

Compression garments

Interventions

NMBM

Daily application of NMBM in addition to compression therapy

Intervention Type: DEVICE

Compression garments

Compression garments

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Lederman Consulting Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shoshana Greenberger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Department of Dermatology, Sheba Medical Center

Locations

The Department of Dermatology, Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA -11- 9204-SG-CTIL

Identifier Type: -

Identifier Source: org_study_id