Trial Outcomes & Findings for The Effect of the Cosmetic Cream NMBM on Leg Ulcers - a Pilot Study (NCT NCT01770509)

NCT ID: NCT01770509

Last Updated: 2017-01-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: From start of treatment to 4 weeks
• Results posted on: 2017-01-11

Participant Flow

Participant milestones

Measure	Standard of Care Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Overall Study STARTED	12	17
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Standard of Care Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Overall Study Injury	0	1
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care n=12 Participants Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM n=17 Participants Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments	Total n=29 Participants Total of all reporting groups
Age, Continuous	75.54 years STANDARD_DEVIATION 7.7 • n=5 Participants	68.17 years STANDARD_DEVIATION 13.9 • n=7 Participants	70.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Gender Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Israel	12 participants n=5 Participants	17 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment to 4 weeks

Population: Analysis is based on measures from each ulcer, when some participants had more than one ulcer

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

Outcome measures

Measure	Standard of Care n=17 Ulcers Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM n=19 Ulcers Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Logarithm of Percentage of Baseline Ulcer Size	3.6043 Mean of log (percentage of baseline area Standard Deviation 2.16636	3.5030 Mean of log (percentage of baseline area Standard Deviation 2.11130

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard of Care n=11 Participants Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM n=14 Participants Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Alleviation of Pain	2.45 units on a scale Standard Deviation 1.29	1.68 units on a scale Standard Deviation 1.62

SECONDARY outcome

Timeframe: 4 weeks

Number of patients with adverse effects at 4 weeks

Outcome measures

Measure	Standard of Care n=11 Participants Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM n=14 Participants Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Incidence of Adverse Events at 4 Weeks	1 Number of patients with adverse events	3 Number of patients with adverse events

SECONDARY outcome

Timeframe: 4 weeks

Number of adverse effects at 4 weeks

Outcome measures

Measure	Standard of Care n=11 Participants Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM n=14 Participants Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Incidence of Adverse Events	1 number of adverse effects	3 number of adverse effects

SECONDARY outcome

Timeframe: 4 weeks

Population: Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Application of NMBM

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard of Care n=11 participants at risk Standard of care: Dressings +Compression garments Compression garments: Compression garments	Application of NMBM n=14 participants at risk Daily application of NMBM NMBM: Daily application of NMBM in addition to compression therapy Compression garments: Compression garments
Skin and subcutaneous tissue disorders local irritation	0.00% 0/11	21.4% 3/14
Skin and subcutaneous tissue disorders wound infection	9.1% 1/11	0.00% 0/14

Additional Information

Dr. Shoshana Greenberger

The Department of Dermatology, Sheba Medical Center

Phone: 972-3-5302443

Email: shoshana.greenberger@sheba.health.gov.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place