Leg Ulcer, Skin Ulcer, Ulcer, Venous Ulcer
Conditions
Keywords
Chronic venous leg ulcers, Venous ulcer, Stasis ulcer, Varicose ulcer
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.
Interventions
DEVICENMBM
Daily application of NMBM in addition to compression therapy
OTHERCompression garments
Compression garments
Sponsors
M.D. Lederman Consulting Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Logarithm of Percentage of Baseline Ulcer Size | From start of treatment to 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alleviation of Pain | 4 weeks | 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 |
| Incidence of Adverse Events at 4 Weeks | 4 weeks | Number of patients with adverse effects at 4 weeks |
| Incidence of Adverse Events | 4 weeks | Number of adverse effects at 4 weeks |
| Time to Complete Closure | 4 weeks | — |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard of care: Dressings +Compression garments
Compression garments: Compression garments | 12 |
| Application of NMBM Daily application of NMBM
NMBM: Daily application of NMBM in addition to compression therapy
Compression garments: Compression garments | 17 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Injury | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Standard of Care | Application of NMBM | Total |
|---|---|---|---|
| Age, Continuous | 75.54 years STANDARD_DEVIATION 7.7 | 68.17 years STANDARD_DEVIATION 13.9 | 70.9 years STANDARD_DEVIATION 12.6 |
| Gender Female | 5 Participants | 9 Participants | 14 Participants |
| Gender Male | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment Israel | 12 participants | 17 participants | 29 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 3 / 14 |
| serious Total, serious adverse events | 0 / 11 | 0 / 14 |
Outcome results
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
Time frame: From start of treatment to 4 weeks
Population: Analysis is based on measures from each ulcer, when some participants had more than one ulcer
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Logarithm of Percentage of Baseline Ulcer Size | 3.6043 Mean of log (percentage of baseline area | Standard Deviation 2.16636 |
| Application of NMBM | Logarithm of Percentage of Baseline Ulcer Size | 3.5030 Mean of log (percentage of baseline area | Standard Deviation 2.1113 |
p-value: 0.652ANOVA
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Alleviation of Pain | 2.45 units on a scale | Standard Deviation 1.29 |
| Application of NMBM | Alleviation of Pain | 1.68 units on a scale | Standard Deviation 1.62 |
p-value: 0.645ANOVA
Secondary
Incidence of Adverse Events
Number of adverse effects at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Incidence of Adverse Events | 1 number of adverse effects |
| Application of NMBM | Incidence of Adverse Events | 3 number of adverse effects |
Secondary
Incidence of Adverse Events at 4 Weeks
Number of patients with adverse effects at 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Incidence of Adverse Events at 4 Weeks | 1 Number of patients with adverse events |
| Application of NMBM | Incidence of Adverse Events at 4 Weeks | 3 Number of patients with adverse events |
Secondary
Time to Complete Closure
Time frame: 4 weeks
Population: Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients