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This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Multi-layer compression bandaging (Profore) |
|
| Celaderm, Bi-Weekly | Experimental | Celaderm, bi-weekly applications, up to a maximum of four applications |
|
| Celaderm, Weekly | Experimental | Celaderm, applied weekly, up to a maximum of four applications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celaderm (Frozen Cultured Epidermal Allograft) | Device | Four biweekly applications of Celaderm plus compression therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. | The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment. | Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs. | 12 Weeks |
| Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Robert Snyder | Tamarac | Florida | 33321 | United States | ||
| National Center for Limb Preservation |
72 patients were consented in this study. Eighteen failed screening: eight had HbA1c > 7%; six failed wound size criteria; one was positive for HIV; one had a normal venous ultrasound; and two withdrew consent. Of the remaining 54 patients, 14 were not randomized: 11 healed > 50% during screening; one had a severe AE; and two more withdrew.
An enrollment of 55 patients was planned to produce an expected yield of approximately 45 evaluable patients at up to nine study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I - Weekly Celaderm | Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing |
| FG001 | Group II - Bi-weekly Celaderm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Celaderm (Frozen Cultured Epidermal Allograft) | Device | Four weekly applications of Celaderm plus compression therapy |
|
|
| Control (compression bandaging) | Device | Multi-layer compression bandaging |
|
|
The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period. |
| Variable - minimum of 12 weeks of follow-up. |
| Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks). | The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period. | 24 weeks |
| Niles |
| Illinois |
| 60714 |
| United States |
| Beth Israel Deaconess Medical Center, Division of Podiatry | Boston | Massachusetts | 02215 | United States |
| State University of New York Stony Brook | Stony Brook | New York | 11794 | United States |
| Center for Curative & Palliative Wound Care, Calvary Hospital | The Bronx | New York | 10461 | United States |
| University of North Carolina at Chapel Hill, Division of Vascular Surgery | Durham | North Carolina | 27599 | United States |
| Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic | Altoona | Pennsylvania | 16602 | United States |
| Peripheral Vascular Associates, P.A. | San Antonio | Texas | 78205 | United States |
| Dixie Regional Medical Center, Wound Care | St. George | Utah | 84770 | United States |
Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
| FG002 | Group III - Control | Adaptic and Profore four-layer compression dressing |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I - Weekly Celaderm | Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing |
| BG001 | Group II - Bi-weekly Celaderm | Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing |
| BG002 | Group III - Control | Adaptic and Profore four-layer compression dressing |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. | The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.) | Intent-to-Treat population (i.e. all subjects randomized to treatment) | Posted | Number | participants | 12 weeks |
|
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| Secondary | Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment. | Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs. | Intent-to-Treat population | Posted | Number | participants | 12 Weeks |
|
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| Secondary | Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period. | The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period. | Intent-to-treat population achieving primary outcome | Posted | Number | participants | Variable - minimum of 12 weeks of follow-up. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks). | The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period. | Intent-to-Treat population | Posted | Number | participants | 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 | Group I - Weekly Celaderm | Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing | 1 | 13 | 3 | 13 | ||
| EG001 | Group II - Bi-weekly Celaderm | Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing | 2 | 15 | 2 | 15 | ||
| EG002 | Group III - Control | Adaptic and Profore four-layer compression dressing | 5 | 12 | 2 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Skin and subcutaneous tissue disorders | Cellulitis of the study or non-study leg |
| ||
| Acute Exacerbation of Chronic Asthma | Respiratory, thoracic and mediastinal disorders |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Critical Limb Ischemia | Vascular disorders |
| |||
| Chest Pain | Cardiac disorders |
| |||
| Swelling | General disorders |
| |||
| Siezure | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcer Infection | Infections and infestations |
|
Limitations of the trial include the potential for outcome assessment bias as the study was not blinded.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| D014647 | Varicose Ulcer |
| D014947 | Wounds and Injuries |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D058128 | Compression Bandages |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Participants |
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