Trial Outcomes & Findings for A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs). (NCT NCT04181320)
NCT ID: NCT04181320
Last Updated: 2024-11-08
Results Overview
Confirmed Complete wound Closure is defined as an blinded assessment and observation of 100% re-epithelialization, confirmed by a second visit 15 days later (+/- 3 days).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
Up to 20 weeks post therapy initiation
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
Venous Leg Ulcer Standard of Care
Subjects will recieve standard of care treatment.
|
Venous Leg Ulcer Standard of Care With Granulox
Subjects will receieve standard of care treatment with Granulox added as an adjunct therapy.
Venous Leg Ulcer Standard of Care with Granulox: Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
62
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).
Baseline characteristics by cohort
| Measure |
Venous Leg Ulcer Standard of Care
n=57 Participants
Subjects will recieve standard of care treatment.
|
Venous Leg Ulcer Standard of Care With Granulox
n=57 Participants
Subjects will recieve standard of care treatment with Granulox added as an adjunct therapy.
Venous Leg Ulcer Standard of Care with Granulox: Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 13 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
70.25 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 20 weeks post therapy initiationConfirmed Complete wound Closure is defined as an blinded assessment and observation of 100% re-epithelialization, confirmed by a second visit 15 days later (+/- 3 days).
Outcome measures
| Measure |
Venous Leg Ulcer Standard of Care
n=57 Participants
Subjects will recieve standard of care treatment.
|
Venous Leg Ulcer Standard of Care With Granulox
n=57 Participants
Subjects will recieve standard of care treatment with Granulox added as an adjunct therapy.
Venous Leg Ulcer Standard of Care with Granulox: Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
|
|---|---|---|
|
Confirmed Complete Wound Closure
Yes
|
11 Participants
|
9 Participants
|
|
Confirmed Complete Wound Closure
No
|
46 Participants
|
48 Participants
|
Adverse Events
Venous Leg Ulcer Standard of Care
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Venous Leg Ulcer Standard of Care With Granulox
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venous Leg Ulcer Standard of Care
n=66 participants at risk
Subjects will recieve standard of care treatment.
|
Venous Leg Ulcer Standard of Care With Granulox
n=62 participants at risk
Subjects will receieve standard of care treatment with Granulox added as an adjunct therapy.
Venous Leg Ulcer Standard of Care with Granulox: Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
|
|---|---|---|
|
General disorders
Inflammation of left leg
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
1.6%
1/62 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Vascular disorders
Stroke (thrombotic)
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
1.6%
1/62 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Musculoskeletal and connective tissue disorders
Motor deficit of the lower limbs and mechanical fall
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
General disorders
Shortness of breath
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Cardiac disorders
Worsening of coronary artery disease (acute myocardial infarction)
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
Other adverse events
| Measure |
Venous Leg Ulcer Standard of Care
n=66 participants at risk
Subjects will recieve standard of care treatment.
|
Venous Leg Ulcer Standard of Care With Granulox
n=62 participants at risk
Subjects will receieve standard of care treatment with Granulox added as an adjunct therapy.
Venous Leg Ulcer Standard of Care with Granulox: Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Deterioration of basalioma on the face
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
1.6%
1/62 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
1.6%
1/62 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Cardiac disorders
Heart arrhythmia
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
1.6%
1/62 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
4.8%
3/62 • Number of events 3 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
General disorders
Inflammation of left leg
|
0.00%
0/66 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
1.6%
1/62 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Infections and infestations
Flu syndrome
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Infections and infestations
Covid-19 infection
|
3.0%
2/66 • Number of events 2 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
|
Skin and subcutaneous tissue disorders
Itching of the body
|
1.5%
1/66 • Number of events 1 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
0.00%
0/62 • Up to 20 weeks post baseline
Number of patients in Patient flow is calculated from FAS which had 114 patients. Participants at risk are taken from the safety population which is greater at 128 patients.
|
Additional Information
Vice President Corporate Clinical & Medical Affairs CMO & RQA
Mölnlycke
Phone: +46317223045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place