Trial Outcomes & Findings for VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6) (NCT NCT04757766)
NCT ID: NCT04757766
Last Updated: 2024-09-19
Results Overview
% of patients with complete healing of the reference venous ulcer after 6 months
Recruitment status
COMPLETED
Target enrollment
350 participants
Primary outcome timeframe
6 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
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|---|---|
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Overall Study
STARTED
|
349
|
|
Overall Study
COMPLETED
|
349
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
n=349 Participants
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
170 Participants
n=349 Participants
|
|
Age, Categorical
>=65 years
|
179 Participants
n=349 Participants
|
|
Age, Continuous
|
60.95 years
STANDARD_DEVIATION 12.71 • n=349 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=349 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=349 Participants
|
|
Region of Enrollment
Russia
|
349 Participants
n=349 Participants
|
PRIMARY outcome
Timeframe: 6 months% of patients with complete healing of the reference venous ulcer after 6 months
Outcome measures
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
n=349 Participants
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
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|---|---|
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Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy
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243 Participants
|
PRIMARY outcome
Timeframe: 6 months% of patients with reduction in the CVD clinical class by CEAP classification
Outcome measures
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
n=349 Participants
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
|
|---|---|
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Eeffectiveness of Systemic Pharmacotherapy
|
247 Participants
|
SECONDARY outcome
Timeframe: 3 months% of patients with healed reference VU after 3 months of treatment
Outcome measures
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
n=349 Participants
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
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|---|---|
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Healing of the Reference Venous Ulcers #1
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47 Participants
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SECONDARY outcome
Timeframe: 6 monthschange in the area of reference VU in cm² (measured with LesionMeter application)
Outcome measures
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
n=349 Participants
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
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|---|---|
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Healing of the Reference Venous Ulcers at Visit 3 vs Baseline
|
8.02 cm²
Standard Deviation 4.06
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Adverse Events
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice
n=349 participants at risk
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time).
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|---|---|
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Gastrointestinal disorders
exacerbation of chronic gastritis
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0.29%
1/349 • Number of events 1 • 6 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place