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Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)

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ClinicalTrials.gov Identifier: NCT00909870
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : February 4, 2013
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Organogenesis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Venous Leg Ulcer
Interventions Device: Dermagraft(R)
Device: Profore
Enrollment 537
Recruitment Details

Screening commenced in May 2009 and ended in November 2010.

Study sites included vascular surgery, dermatology, and podiatry clinics.

A total of 913 potential subjects were screened across 58 study centers; 395 subjects were screen failures.

A total of 537 subjects were enrolled across 49 study centers.

Pre-assignment Details Prior to study enrollment, all subjects signing informed consent proceeded through a two-week run-in phase in which all subjects received standard-of-care study ulcer treatment. During this phase, any subject not meeting inclusion/exclusion criteria was considered a screen failure and removed from the study.
Arm/Group Title Investigational Treatment (Dermagraft Plus Standard-of-Care) Active Control (Standard-of-Care)
Hide Arm/Group Description Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Period Title: Overall Study
Started 274 263
Completed 251 236
Not Completed 23 27
Reason Not Completed
Adverse Event             13             7
Protocol Violation             1             2
Withdrawal by Subject             5             8
Lost to Follow-up             3             3
Physician Decision             0             2
Other             1             5
Arm/Group Title Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care) Total
Hide Arm/Group Description Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. Weekly application of compression dressings only, in combination with systematic surgical wound debridement. Total of all reporting groups
Overall Number of Baseline Participants 274 263 537
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 263 participants 537 participants
63.1  (13.04) 63.2  (14.46) 63.1  (13.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 263 participants 537 participants
Female
158
  57.7%
146
  55.5%
304
  56.6%
Male
116
  42.3%
117
  44.5%
233
  43.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 274 participants 263 participants 537 participants
United States 94 93 187
Estonia 10 9 19
Poland 81 74 155
South Africa 73 71 144
Germany 8 8 16
United Kingdom 6 7 13
Sweden 2 1 3
Ulcer Size  
Median (Full Range)
Unit of measure:  Centimeters-squared
Number Analyzed 274 participants 263 participants 537 participants
5.75
(1.5 to 19.3)
5.90
(2.0 to 24.8)
5.9
(1.5 to 24.8)
Ulcer Duration  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 274 participants 263 participants 537 participants
206
(1 to 18157)
228
(23 to 3834)
214
(1 to 18157)
1.Primary Outcome
Title Complete Healing of the Study Ulcer by Week 16.
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population
Arm/Group Title Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care)
Hide Arm/Group Description:
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Overall Number of Participants Analyzed 274 263
Measure Type: Number
Unit of Measure: participants
201 176
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Treatment (Dermagraft Plus Standard-of-Care), Control (Standard-of-Care)
Comments

H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.

HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.

The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1030
Comments This p-value did not meet the prespecified threshold for statistical significance of < 0.05
Method Chi-squared
Comments Unadjusted
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 6.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time-to-Complete Healing
Hide Description Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
Time Frame From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population
Arm/Group Title Investigational Treatment (Dermagraft Plus Standard-of=- Care) Control (Standard-of-Care)
Hide Arm/Group Description:
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Overall Number of Participants Analyzed 274 263
Median (Inter-Quartile Range)
Unit of Measure: days
58
(36 to 113)
64
(36 to 113)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Treatment (Dermagraft Plus Standard-of=- Care), Control (Standard-of-Care)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4046
Comments This p-value did not meet the prespecified threshold for statistical significance of < 0.05
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 6
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Complete Healing by Week 16: Ulcers <= 12 Months Duration
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-specified Subgroup of the Intent-to-Treat Population
Arm/Group Title Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care)
Hide Arm/Group Description:
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Overall Number of Participants Analyzed 198 189
Measure Type: Number
Unit of Measure: participants
158 132
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Treatment (Dermagraft Plus Standard-of-Care), Control (Standard-of-Care)
Comments Pre-specified subgroup analysis of the primary endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0239
Comments Unadjusted
Method Chi-squared
Comments Unadjusted
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 10.0
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care)
Hide Arm/Group Description Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
All-Cause Mortality
Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/274 (10.22%)      24/263 (9.13%)    
Blood and lymphatic system disorders     
Anemia  1/274 (0.36%)  1 0/263 (0.00%)  0
Cardiac disorders     
Acute Myocardial Infarction  0/274 (0.00%)  0 1/263 (0.38%)  1
Angina Unstable  0/274 (0.00%)  0 1/263 (0.38%)  1
Atrial Fibrilation  0/274 (0.00%)  0 3/263 (1.14%)  3
Cardiac Failure  0/274 (0.00%)  0 1/263 (0.38%)  1
Cardiac failure congestive  0/274 (0.00%)  0 2/263 (0.76%)  2
Cardio-respiratory arrest  0/274 (0.00%)  0 1/263 (0.38%)  1
Coronary artery disease  1/274 (0.36%)  1 0/263 (0.00%)  0
Myocardial infarction  1/274 (0.36%)  1 0/263 (0.00%)  0
Sick Sinus Syndrome  0/274 (0.00%)  0 1/263 (0.38%)  1
Gastrointestinal disorders     
Constipation  1/274 (0.36%)  1 0/263 (0.00%)  0
Diarrhea  0/274 (0.00%)  0 1/263 (0.38%)  1
Gastrointestinal haemorrhage  0/274 (0.00%)  0 1/263 (0.38%)  1
Inguinal hernia  0/274 (0.00%)  0 1/263 (0.38%)  1
General disorders     
Asthenia  1/274 (0.36%)  1 1/263 (0.38%)  1
Death  3/274 (1.09%)  3 2/263 (0.76%)  2
Drug intolerance  1/274 (0.36%)  1 0/263 (0.00%)  0
Oedema peripheral  0/274 (0.00%)  0 1/263 (0.38%)  1
Infections and infestations     
Abscess  1/274 (0.36%)  1 0/263 (0.00%)  0
Abscess limb  1/274 (0.36%)  1 0/263 (0.00%)  0
Appendicitis  0/274 (0.00%)  0 1/263 (0.38%)  1
Bronchitis  0/274 (0.00%)  0 2/263 (0.76%)  2
Cellulitis  2/274 (0.73%)  2 1/263 (0.38%)  1
Clostridial infection  1/274 (0.36%)  1 0/263 (0.00%)  0
Gastroenteritis  0/274 (0.00%)  0 1/263 (0.38%)  1
Infected skin ulcer  2/274 (0.73%)  2 2/263 (0.76%)  2
Laryngitis  0/274 (0.00%)  0 1/263 (0.38%)  1
Lower respiratory tract infection  1/274 (0.36%)  1 0/263 (0.00%)  0
Pelvic abscess  0/274 (0.00%)  0 1/263 (0.38%)  1
Peritonitis bacterial  1/274 (0.36%)  1 0/263 (0.00%)  0
Pneumonia  2/274 (0.73%)  2 3/263 (1.14%)  3
Sepsis  1/274 (0.36%)  1 1/263 (0.38%)  1
Upper respiratory tract infection  0/274 (0.00%)  0 1/263 (0.38%)  1
Urinary tract infection  1/274 (0.36%)  1 0/263 (0.00%)  0
Injury, poisoning and procedural complications     
Facial bones fractures  0/274 (0.00%)  0 1/263 (0.38%)  1
Hip fracture  1/274 (0.36%)  1 0/263 (0.00%)  0
Pelvic fracture  0/274 (0.00%)  0 1/263 (0.38%)  1
Post procedural haematoma  1/274 (0.36%)  1 0/263 (0.00%)  0
Investigations     
Angiogram  0/274 (0.00%)  0 1/263 (0.38%)  1
Cardiac stress test  0/274 (0.00%)  0 1/263 (0.38%)  1
Metabolism and nutrition disorders     
Hypoglycemia  1/274 (0.36%)  1 1/263 (0.38%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1/274 (0.36%)  1 0/263 (0.00%)  0
Joint effusion  0/274 (0.00%)  0 1/263 (0.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm  0/274 (0.00%)  0 1/263 (0.38%)  1
Lung neoplasm malignant  0/274 (0.00%)  0 1/263 (0.38%)  1
Nervous system disorders     
Cerebrovascular accident  1/274 (0.36%)  1 0/263 (0.00%)  0
Epilepsy  0/274 (0.00%)  0 1/263 (0.38%)  1
Subarachnoid haemorrhage  0/274 (0.00%)  0 1/263 (0.38%)  1
Renal and urinary disorders     
Haematuria  1/274 (0.36%)  1 0/263 (0.00%)  0
Renal failure acute  1/274 (0.36%)  1 0/263 (0.00%)  0
Reproductive system and breast disorders     
Vaginal haemorrhage  1/274 (0.36%)  1 0/263 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1/274 (0.36%)  1 0/263 (0.00%)  0
Chronic obstructive pulmonary disease  0/274 (0.00%)  0 1/263 (0.38%)  1
Cough  0/274 (0.00%)  0 1/263 (0.38%)  1
Dyspnoea  0/274 (0.00%)  0 1/263 (0.38%)  1
Interstitial lung disease  0/274 (0.00%)  0 1/263 (0.38%)  1
Pulmonary embolism  1/274 (0.36%)  1 0/263 (0.00%)  0
Pulmonary oedema  1/274 (0.36%)  1 0/263 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythema  0/274 (0.00%)  0 1/263 (0.38%)  1
Pupura  0/274 (0.00%)  0 1/263 (0.38%)  1
Surgical and medical procedures     
Implantable defibrilator replacement  1/274 (0.36%)  1 0/263 (0.00%)  0
Inguinal hernia repair  0/274 (0.00%)  0 1/263 (0.38%)  1
Therapy regimen changed  2/274 (0.73%)  2 0/263 (0.00%)  0
Varicose vein operation  0/274 (0.00%)  0 1/263 (0.38%)  1
Venous operation  1/274 (0.36%)  1 0/263 (0.00%)  0
Vascular disorders     
Hypertension  1/274 (0.36%)  1 0/263 (0.00%)  0
Hypertensive crisis  0/274 (0.00%)  0 1/263 (0.38%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Investigational Treatment (Dermagraft Plus Standard-of-Care) Control (Standard-of-Care)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   168/274 (61.31%)      157/263 (59.70%)    
Infections and infestations     
Infected skin ulcer  22/274 (8.03%)  22 25/263 (9.51%)  25
Nasopharyngitis  18/274 (6.57%)  18 18/263 (6.84%)  18
Injury, poisoning and procedural complications     
Excoriation  20/274 (7.30%)  20 16/263 (6.08%)  16
Musculoskeletal and connective tissue disorders     
Pain in extremity  17/274 (6.20%)  17 25/263 (9.51%)  25
Skin and subcutaneous tissue disorders     
Skin Ulcer  77/274 (28.10%)  77 60/263 (22.81%)  60
Vascular disorders     
Hypertension  14/274 (5.11%)  14 13/263 (4.94%)  13
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Company-specific confidentiality agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mollie Carter, MD, Medical Director
Organization: Shire Regenerative Medicine
Phone: (858) 754-5678
EMail: mcarter@shire.com
Layout table for additonal information
Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT00909870    
Other Study ID Numbers: ABH-Dermagraft-001-08
First Submitted: May 28, 2009
First Posted: May 29, 2009
Results First Submitted: December 31, 2012
Results First Posted: February 4, 2013
Last Update Posted: June 18, 2018