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| Name | Class |
|---|---|
| Health Research Council, New Zealand | OTHER |
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Venous leg ulcers (VLU) are the most common leg ulcer, can be painful, and limit work, lifestyles and activity, especially in older patients. There are few effective treatments - compression therapy (tight bandaging or stockings) helps healing, but about half the people with a VLU remain unhealed even after 12 weeks of treatment. Research suggests taking aspirin as well as using compression may speed up healing for VLU, but the current evidence is not enough to change clinical practice. We will conduct a randomised controlled trial to test whether using low dose aspirin (150 mg daily or placebo) really does speed up healing.
A pragmatic, community based, double-blind, placebo-controlled, randomised trial to determine whether low dose aspirin accelerates venous leg ulcer healing at 24 weeks when used in addition to compression. Participants in have compression therapy (system of choice guided by patient and/or clinical preference) as delivered through district nursing services at the study centres as a background treatment. Low dose aspirin (150 mg) or placebo will be taken once daily as an oral capsule.
Participants will be district nursing service patients in five study centres in New Zealand with prevalent or incident venous leg ulcers. A venous leg ulcer will be defined as a wound on the lower leg that has remained unhealed for 4 or more weeks, appears to be primarily venous in aetiology with other causative diseases ruled out. If the participant has two or more venous leg ulcers, the largest ulcer will be the reference ulcer.
Participants will receive three visits from the research nurse - visit 1 to screen for eligibility, visit 2 to consent and randomise the participant, visit 3 to collect outcome data. District nurses will continue to visit the participant (about weekly or more frequently if required) to provide routine care between research nurse visits.
Block randomisation will be used, stratified by study centre and prognostic index (ulcer size greater than 5cm2 and ulcer duration greater than 6 months) to ensure a balance of participants within study centres and for participants likely to be slow healers. Research nurses in the study centres will contact a central telephone answering service, provide information on inclusion criteria, exclusion criteria, and relevant clinical history on consented participants. Randomised participants will receive a bottle of 168 capsules of study medication identified only by unique code and will take the capsule until the reference ulcer heals or up to 24 weeks, whichever occurs sooner.
Participants will take the study medication for up to 24 weeks or until the reference ulcer heals. If the participant has a serious adverse event, needs to start taking aspirin, or must stop taking aspirin to use other medications, they will be withdrawn from treatment, although they will still be followed up at 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | 150 mg capsule once daily for up to 24 weeks |
|
| Inert capsule | Placebo Comparator | Matching capsule once daily for up to 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 150 mg aspirin in capsule form once daily for up to 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Healing of Reference Ulcer | Time to event (complete healing defined as intact skin with absence of scab) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Healed Venous Leg Ulcers | Number of participants in each arm with completely healed reference ulcers at 24 weeks | 24 weeks |
| Change in Estimated Ulcer Area | Change in estimated ulcer area from baseline to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Jull, RN PhD | School of Nursing, University of Auckland | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26708314 | Background | Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU). J Adv Nurs. 2016 Mar;72(3):669-79. doi: 10.1111/jan.12864. Epub 2015 Dec 28. | |
| 29175902 | Derived | Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J. Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic, randomised, double blind, placebo controlled trial (Aspirin4VLU). BMJ. 2017 Nov 24;359:j5157. doi: 10.1136/bmj.j5157. |
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We have a plan to share individual participant data with other aspirin for VLU triallists. All other requests for de-identified individual participant data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the Trial Steering Committee, and the requestor is willing to sign a data access agreement.
No limitations to timeframe
We have a plan to share individual participant data with other aspirin for VLU triallists. All other requests for de-identified individual participant data or study documents will be considered where the proposed use aligns with public good purposes, does not conflict with other requests, or planned use by the Trial Steering Committee, and the requestor is willing to sign a data access agreement.
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Enrolled participants were required to have their family physician confirm they could safely participate in the trial ie had no conditions that required treatment with aspirin and no conditions that contraindicated use of aspirin.
Participants were screened and recruited from five study sites in New Zealand
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin | 150 mg capsule once daily for up to 24 weeks Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks |
| FG001 | Placebo | Matching inert capsule once daily for up to 24 weeks Placebo: Matching placebo capsule containing inert bulking agent |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin | 150 mg capsule once daily for up to 24 weeks Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks |
| BG001 | Placebo | Matching inert capsule once daily for up to 24 weeks Placebo: Matching placebo capsule containing inert bulking agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Complete Healing of Reference Ulcer | Time to event (complete healing defined as intact skin with absence of scab) | Posted | Median | 95% Confidence Interval | days | 24 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin | 150 mg capsule once daily for up to 24 weeks Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation or prolongation of hospitalisation | Infections and infestations | ICD-10 AM | Systematic Assessment | Staphylococcal infection, unspecified site |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | ICD-10 AM | Systematic Assessment | Other specified respiratory disorders |
Recruitment was lower than anticipated as fewer aspirin-naive patients being available than estimated. However we had 82% power to observe the anticipated difference if assumptions had been correct.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Andrew Jull | University of Auckland | +64 9 923 4259 | a.jull@auckland.ac.nz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2015 | Nov 14, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2015 | Nov 14, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2014 | Nov 14, 2018 | ICF_002.pdf |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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Identical placebo with only difference being unique code on bottle containing product.
| Placebo |
| Drug |
Matching placebo capsule containing inert bulking agent |
|
| Baseline, 24 weeks |
| Change in Health-related Quality of Life (Short Form 36) | Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group. | Baseline, 24 weeks |
| Change in Health-related Quality of Life (EuroQol-5D 3L) | Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group. | Baseline, 24 weeks |
| Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire) | Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group. | 24 weeks |
| Number of Participants With Adherence to Treatment | Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing) | 24 weeks |
| Incidence of Adverse Events at 24 Weeks | Total number of different types of adverse events in participants who reported with any untoward medical event | 24 weeks |
| Lost to Follow-up |
|
| Moved out of area |
|
| Transferred to palliative care |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Highest educational attainment | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Medical history | Count of Participants | Participants |
|
| Ankle Brachial Index | Mean | Standard Deviation | Ratio of SBP ankle/SBP arm |
|
| Reference ulcer area | Median | Inter-Quartile Range | square centimetres |
|
| Compression system | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Healed Venous Leg Ulcers | Number of participants in each arm with completely healed reference ulcers at 24 weeks | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
|
| Secondary | Change in Estimated Ulcer Area | Change in estimated ulcer area from baseline to 24 weeks | Ulcer area estimated using maximum width and length of the ulcer to calculate the area of an ellipse. We have previously shown this approach to be highly correlated with digital calculation of measured area (r=0.92). | Posted | Mean | Standard Error | square centimetres | Baseline, 24 weeks |
|
|
|
|
| Secondary | Change in Health-related Quality of Life (Short Form 36) | Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group. | Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomized. | Posted | Mean | Standard Error | units on a scale | Baseline, 24 weeks |
|
|
|
|
| Secondary | Change in Health-related Quality of Life (EuroQol-5D 3L) | Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group. | Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised. | Posted | Mean | Standard Error | score on a scale | Baseline, 24 weeks |
|
|
|
|
| Secondary | Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire) | Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group. | Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised. | Posted | Mean | Standard Error | score on a scale | 24 weeks |
|
|
|
|
| Secondary | Number of Participants With Adherence to Treatment | Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing) | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
|
| Secondary | Incidence of Adverse Events at 24 Weeks | Total number of different types of adverse events in participants who reported with any untoward medical event | Only participants that reported any reported untoward medical event were included in this analysis. | Posted | Count of Units | Number of events | No | 24 weeks | Number of events | Number of events |
|
|
|
|
| 2 |
| 125 |
| 11 |
| 125 |
| 20 |
| 125 |
| EG001 | Placebo | Matching inert capsule once daily for up to 24 weeks Placebo: Matching placebo capsule containing inert bulking agent | 0 | 126 | 10 | 126 | 18 | 126 |
|
| Hospitalisation or prolongation of hospitalisation | Infections and infestations | Study specific code | Systematic Assessment | Infection of ulceration |
|
| Hospitalisation or prolongation of hospitalisation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 AM | Systematic Assessment | Metastatic squamous cell carcinoma |
|
| Hospitalisation or prolongation of hospitalisation | Cardiac disorders | ICD-10 AM | Systematic Assessment | Other cardiomyopathies |
|
| Hospitalisation or prolongation of hospitalisation | Blood and lymphatic system disorders | ICD-10 AM | Systematic Assessment | Phlebitis and thrombophlebitis of other deep vessels of lower extremities |
|
| Hospitalisation or prolongation of hospitalisation | Respiratory, thoracic and mediastinal disorders | ICD-10 AM | Systematic Assessment | Pneumonitis due to food and vomit |
|
| Hospitalisation or prolongation of hospitalisation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment | Volvulus |
|
| Hospitalisation or prolongation of hospitalisation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment | Constipation |
|
| Hospitalisation or prolongation of hospitalisation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment | Haemorrhage of anus and rectum |
|
| Hospitalisation or prolongation of hospitalisation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment | Gastrointestinal haemorrhage, unspecified |
|
| Hospitalisation or prolongation of hospitalisation | Infections and infestations | ICD-10 AM | Systematic Assessment | Cellulitis of lower limb |
|
| Hospitalisation or prolongation of hospitalisation | Renal and urinary disorders | ICD-10 AM | Systematic Assessment | Acute kidney failure, unspecified |
|
| Hospitalisation or prolongation of hospitalisation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment | Pharyngeal pouch |
|
| Hospitalisation or prolongation of hospitalisation | Blood and lymphatic system disorders | ICD-10 AM | Systematic Assessment | Epistaxis |
|
| Hospitalisation or prolongation of hospitalisation | Cardiac disorders | ICD-10 AM | Systematic Assessment | Chest pain, unspecified |
|
| Hospitalisation or prolongation of hospitalisation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment | Other and unspecified abdominal pain |
|
| Hospitalisation or prolongation of hospitalisation | Cardiac disorders | ICD-10 AM | Systematic Assessment | Syncope and collapse |
|
| Hospitalisation or prolongation of hospitalisation | General disorders | ICD-10 AM | Systematic Assessment | Malaise and fatigue |
|
| Hospitalisation or prolongation of hospitalisation | Injury, poisoning and procedural complications | ICD-10 AM | Systematic Assessment | Fracture shaft of tibia with fracture of fibula (any part) |
|
| Hospitalisation or prolongation of hospitalisation | Surgical and medical procedures | ICD-10 AM | Systematic Assessment | Presence of hip implant |
|
| Life threatening event of illness | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 AM | Systematic Assessment | Malignant neoplasm of brain, unspecified |
|
| Significan medical event | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 AM | Systematic Assessment | Malignant neoplasm of breast, unspecified part |
|
| Significant medical event | Immune system disorders | ICD-10 AM | Systematic Assessment | Allergy, unspecified |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ICD-10 AM | Systematic Assessment | Malignant neoplasm of prostate |
|
| Death | Respiratory, thoracic and mediastinal disorders | ICD-10 AM | Systematic Assessment | Other unspecified respiratory disorder |
|
|
| Bleeding from any lower leg ulceration | Blood and lymphatic system disorders | Study specific code | Systematic Assessment |
|
| Infection of ulceration, any lower leg ulceration | Infections and infestations | Study specific code | Systematic Assessment |
|
| Developed any new lower leg ulceration | Skin and subcutaneous tissue disorders | Study specific code | Systematic Assessment |
|
| Extension of reference ulceration | Skin and subcutaneous tissue disorders | Study specific code | Systematic Assessment | Including incorporation of other ulcers into reference ulcer |
|
| Candidal stomatitis | Infections and infestations | ICD-10 AM | Systematic Assessment |
|
| Coagulation defect, unspecified | Blood and lymphatic system disorders | ICD-10 AM | Systematic Assessment | Longer bleeding time on small cuts to hands |
|
| Depressive episode, unspecified | Psychiatric disorders | ICD-10 AM | Systematic Assessment |
|
| Acute inflammation of orbit | Skin and subcutaneous tissue disorders | ICD-10 AM | Systematic Assessment |
|
| Varicose veins of lower extremities with inflammation | Skin and subcutaneous tissue disorders | ICD-10 AM | Systematic Assessment |
|
| Varicose veins of lower extremities without ulcer or inflammation | Vascular disorders | ICD-10 AM | Systematic Assessment | Saphenous femoral junction incompetence, other leg |
|
| Gastro-oesophageal reflux disease without oesophagi's | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment |
|
| Gastric ulcer, unspecified as acute or chronic, without haemorrhage or perforation | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment |
|
| Gastritis, unspecified | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment |
|
| Functional diarrhoea | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment |
|
| Cellulitis of lower limb | Skin and subcutaneous tissue disorders | ICD-10 AM | Systematic Assessment |
|
| Urinary tract infection, site not specified | Renal and urinary disorders | ICD-10 AM | Systematic Assessment |
|
| Epistaxis | Blood and lymphatic system disorders | ICD-10 AM | Systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | ICD-10 AM | Systematic Assessment |
|
| Tendency to fall, not elsewhere classified | Injury, poisoning and procedural complications | ICD-10 AM | Systematic Assessment |
|
| Hyperhidrosis | General disorders | ICD-10 AM | Systematic Assessment |
|
| Laceration and contusions | Injury, poisoning and procedural complications | ICD-10 AM | Systematic Assessment |
|
| Allergy, unspecified | Immune system disorders | ICD-10 AM | Systematic Assessment |
|
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Bodily Pain |
|
| General Health |
|
| Vitality |
|
| Social Functioning |
|
| Role Emotional |
|
| Mental Health |
|
| Regression, Linear |
Adjusted for baseline values |
| 0.768 |
| Mean Difference (Net) |
| 1.4 |
| 2-Sided |
| 95 |
| -8.0 |
| 10.8 |
| Superiority |
| Change in Bodily Pain | Regression, Linear | Adjusted for baseline values | 0.449 | Mean Difference (Net) | 2.3 | 2-Sided | 95 | -3.7 | 8.4 | Superiority |
| Change in General Health | Regression, Linear | Adjusted for baseline values | 0.873 | Mean Difference (Net) | -0.3 | 2-Sided | 95 | -4.3 | 3.6 | Superiority |
| Change in Vitality | Regression, Linear | Adjusted for baseline values | 0.057 | Mean Difference (Net) | 4.2 | 2-Sided | 95 | -0.1 | 8.5 | Superiority |
| Change in Social Functioning | Regression, Linear | Adjusted for baseline values | 0.756 | Mean Difference (Net) | 1.0 | 2-Sided | 95 | -5.1 | 7.0 | Superiority |
| Change in Role Emotional | Regression, Linear | Adjusted for baseline values | 0.400 | Mean Difference (Net) | 3.7 | 2-Sided | 95 | -4.9 | 12.3 | Superiority |
| Change in Mental Health | Regression, Linear | Adjusted for baseline values | 0.236 | Mean Difference (Net) | -2.3 | 2-Sided | 95 | -6.2 | 1.5 | Superiority |
| Cosmesis |
|
| Emotional status |
|
| Overall |
|
| Regression, Linear |
Adjusted for baseline values |
| 0.408 |
| Mean Difference (Net) |
| -1.3 |
| 2-Sided |
| 95 |
| -4.5 |
| 1.9 |
| Superiority |
| Change in cosmesis | Regression, Linear | Adjusted for baseline values | 0.568 | Mean Difference (Net) | -1.3 | 2-Sided | 95 | -5.6 | 3.1 | Superiority |
| Change in emotional status | Regression, Linear | Adjusted for baseline values | 0.257 | Mean Difference (Net) | -3.0 | 2-Sided | 95 | -8.1 | 2.2 | Superiority |
| Regression, Linear | Adjusted for baseline values | 0.273 | Mean Difference (Net) | -1.9 | 2-Sided | 95 | -5.2 | 1.5 | Superiority |
| Gastrointestinal |
|
| Respiratory |
|
| Genitourinary |
|
| Skin & cutaneous |
|
| Accidental injury |
|
| Psychiatric |
|
| Signs & symptoms |
|
| Leg ulcer bleeding |
|
| Leg ulcer infection |
|
| Extension of leg ulcer |
|
| New leg ulcer |
|
| Other |
|