Trial Outcomes & Findings for Compression Hosiery to Avoid Post-Thrombotic Syndrome (NCT NCT04103112)
NCT ID: NCT04103112
Last Updated: 2024-03-07
Results Overview
Measured using the validated Villalta criteria
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
30 months
Results posted on
2024-03-07
Participant Flow
Participant milestones
| Measure |
Standard Clinical Care
Standard clinical care (anticoagulation) with no graduated compression stocking
|
Graduated Compression Stocking and Standard Clinical Care
A graduated compression stocking and the standard clinical care (anticoagulation)
Graduated compression stocking: Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
COMPLETED
|
55
|
56
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compression Hosiery to Avoid Post-Thrombotic Syndrome
Baseline characteristics by cohort
| Measure |
Standard Clinical Care
n=76 Participants
Standard clinical care (anticoagulation) with no graduated compression stocking
|
Graduated Compression Stocking and Standard Clinical Care
n=76 Participants
A graduated compression stocking and the standard clinical care (anticoagulation)
Graduated compression stocking: Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 14.2 • n=99 Participants
|
56.2 years
STANDARD_DEVIATION 14.8 • n=107 Participants
|
57.3 years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
66 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed Race/Multiple Ethnic Background
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or Black British
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
76 participants
n=99 Participants
|
76 participants
n=107 Participants
|
152 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 monthsMeasured using the validated Villalta criteria
Outcome measures
| Measure |
Standard Clinical Care
n=55 Participants
Standard clinical care (anticoagulation) with no graduated compression stocking
|
Graduated Compression Stocking and Standard Clinical Care
n=56 Participants
A graduated compression stocking and the standard clinical care (anticoagulation)
Graduated compression stocking: Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.
|
|---|---|---|
|
Incidence of Post Thrombotic Syndrome (PTS)
Index-Leg
|
28 Number of PTS events
|
17 Number of PTS events
|
|
Incidence of Post Thrombotic Syndrome (PTS)
Non-Index-Leg
|
6 Number of PTS events
|
9 Number of PTS events
|
SECONDARY outcome
Timeframe: 30 monthsMeasured using the validated Villalta criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsChange in number of days working from baseline
Outcome measures
| Measure |
Standard Clinical Care
n=76 Participants
Standard clinical care (anticoagulation) with no graduated compression stocking
|
Graduated Compression Stocking and Standard Clinical Care
n=76 Participants
A graduated compression stocking and the standard clinical care (anticoagulation)
Graduated compression stocking: Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.
|
|---|---|---|
|
Employment Status
Full time
|
34 Participants
|
34 Participants
|
|
Employment Status
Part time
|
8 Participants
|
9 Participants
|
|
Employment Status
Unemployed
|
7 Participants
|
5 Participants
|
|
Employment Status
Retired
|
26 Participants
|
27 Participants
|
|
Employment Status
Student
|
1 Participants
|
0 Participants
|
|
Employment Status
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 monthsMeasured using VEINES-QoL scale (instrument to measure quality of life in deep venous thrombosis). Two summary scores can be computed. The VEINES-QOL summary score (25 items) provides an estimate of the overall impact of deep venous thrombosis on the patient's quality of life. The VEINES-Sym summary score (10 items) measures symptom severity. Higher scores indicate better outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsMeasured using EuroQoL EQ5D scale (European Quality of Life 5D instrument for measuring generic health status) . A health index on a score of 0 to 1 and the participants' self-rated health on a vertical score of zero to 100. Higher scores indicate better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsPatient self-report - at six months median follow up, the criteria for continuing CHAPS is equal to or over 70% of participants wearing stockings (monthly self-reported patient adherence questionnaire) for equal to or over 4 days per week in the intervention arm, along with a documented reorder of stockings within the last 6 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 monthsIncremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis
Outcome measures
Outcome data not reported
Adverse Events
Standard Clinical Care
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
Graduated Compression Stocking and Standard Clinical Care
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Clinical Care
n=76 participants at risk
Standard clinical care (anticoagulation) with no graduated compression stocking
|
Graduated Compression Stocking and Standard Clinical Care
n=76 participants at risk
A graduated compression stocking and the standard clinical care (anticoagulation)
Graduated compression stocking: Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left posterior Stroke; PE
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Nervous system disorders
Acute MCA infarction
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Blood and lymphatic system disorders
Admitted with nose bleed and pr bleed; rectal ca with mets - on palliative chemotherapy
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Blood and lymphatic system disorders
Pr bleeding, thrombocytopaenia
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Blood and lymphatic system disorders
Dizziness, collapse, black stools, lack of appetite
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
Other adverse events
| Measure |
Standard Clinical Care
n=76 participants at risk
Standard clinical care (anticoagulation) with no graduated compression stocking
|
Graduated Compression Stocking and Standard Clinical Care
n=76 participants at risk
A graduated compression stocking and the standard clinical care (anticoagulation)
Graduated compression stocking: Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling.
|
|---|---|---|
|
Vascular disorders
Varicose veins
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Vascular disorders
Edema
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Metabolism and nutrition disorders
Gout flare-ups increased in severity since taking warfarin; patient noted an increase in pain
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Vascular disorders
Leg pain and swelling to left leg.
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Musculoskeletal and connective tissue disorders
Discomfort of fifth toe
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Musculoskeletal and connective tissue disorders
Indentation from stocking
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Musculoskeletal and connective tissue disorders
Soreness medial aspect of the shin
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Nervous system disorders
Pins and needles at the end of first full day of wearing stockings
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Musculoskeletal and connective tissue disorders
Bruising to leg
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Vascular disorders
Patient seen by vascular team and advised to wear class II hoisery
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
|
Vascular disorders
Acute & chronic DVT of left leg
|
0.00%
0/76 • Through participant's study completion, 6-30 months (median 18 months)
|
1.3%
1/76 • Through participant's study completion, 6-30 months (median 18 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place