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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Standard of care: Dressings +Compression garments |
|
| Application of NMBM | Experimental | Daily application of NMBM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMBM | Device | Daily application of NMBM in addition to compression therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Alleviation of Pain | Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain | 4 weeks |
| Incidence of Adverse Events at 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Shoshana Greenberger, MD PhD | The Department of Dermatology, Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Department of Dermatology, Sheba Medical Center | Ramat Gan | 52621 | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard of care: Dressings +Compression garments Compression garments: Compression garments |
| FG001 | Application of NMBM | Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard of care: Dressings +Compression garments Compression garments: Compression garments |
| BG001 | Application of NMBM | Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis is based on measures from each ulcer, when some participants had more than one ulcer | Posted | Mean | Standard Deviation | Mean of log (percentage of baseline area | From start of treatment to 4 weeks | Ulcers | Ulcers |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Standard of care: Dressings +Compression garments Compression garments: Compression garments |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| local irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Local erythema or burning |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shoshana Greenberger | The Department of Dermatology, Sheba Medical Center | 972-3-5302443 | shoshana.greenberger@sheba.health.gov.il |
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| ID | Term |
|---|---|
| D014456 | Ulcer |
| D014647 | Varicose Ulcer |
| D012883 | Skin Ulcer |
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
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| Compression garments |
| Other |
Compression garments |
|
Number of patients with adverse effects at 4 weeks
| 4 weeks |
| Incidence of Adverse Events | Number of adverse effects at 4 weeks | 4 weeks |
| Time to Complete Closure | 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Secondary | Alleviation of Pain | Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
|
| Secondary | Incidence of Adverse Events at 4 Weeks | Number of patients with adverse effects at 4 weeks | Posted | Number | Number of patients with adverse events | 4 weeks |
|
|
|
| Secondary | Incidence of Adverse Events | Number of adverse effects at 4 weeks | Posted | Number | number of adverse effects | 4 weeks |
|
|
|
| Secondary | Time to Complete Closure | Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients | Posted | 4 weeks |
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Application of NMBM | Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments | 0 | 14 | 3 | 14 |
|
| wound infection | Skin and subcutaneous tissue disorders | Systematic Assessment | Secondary infection of wound treated by antibiotics |
|
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| D002318 | Cardiovascular Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |