The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Hadassah Medical Organization
Information provided by (Responsible Party):
Galia Spectre, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01637428
First received: June 13, 2012
Last updated: July 15, 2012
Last verified: July 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 13, 2012 | ||||||||
| Last Updated Date | July 15, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Quality of life (Veins-QOL) [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01637428 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Villalta Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ] The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, pruritus) and six clinician-rated physical signs (pretibial edema, skin induration, hyperpigmentation,pain during calf compression, venous ectasia, redness),which are each rated on a four-point scale (0 = none,1 = mild, 2 = moderate, 3 = severe). Points are summed to produce a total score (range: 0-33). Subjects are classified as having Post Thrombotic Syndrome if the score is 5 or more, or if a venous ulcer is present, in a leg with previous DVT. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome | ||||||||
| Official Title ICMJE | The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome | ||||||||
| Brief Summary | The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Post Thrombotic Syndrome | ||||||||
| Intervention ICMJE | Device: ActiveCare+S.F.T 3rd generation
Intermittent Pneumatic Compression Device |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Israel | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01637428 | ||||||||
| Other Study ID Numbers ICMJE | 727209-HMO-CTIL | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | Not Provided | ||||||||
| Responsible Party | Galia Spectre, Hadassah Medical Organization | ||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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