Trial Outcomes & Findings for Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (NCT NCT00909870)
NCT ID: NCT00909870
Last Updated: 2018-06-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
537 participants
Primary outcome timeframe
16 weeks
Results posted on
2018-06-18
Participant Flow
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.
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.
Participant milestones
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Active Control (Standard-of-Care)
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Overall Study
STARTED
|
274
|
263
|
|
Overall Study
COMPLETED
|
251
|
236
|
|
Overall Study
NOT COMPLETED
|
23
|
27
|
Reasons for withdrawal
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Active Control (Standard-of-Care)
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
7
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Other
|
1
|
5
|
Baseline Characteristics
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
n=274 Participants
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Control (Standard-of-Care)
n=263 Participants
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
Total
n=537 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 Years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 14.46 • n=7 Participants
|
63.1 Years
STANDARD_DEVIATION 13.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
93 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
81 participants
n=5 Participants
|
74 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
73 participants
n=5 Participants
|
71 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Ulcer Size
|
5.75 centimeters-squared
n=5 Participants
|
5.90 centimeters-squared
n=7 Participants
|
5.9 centimeters-squared
n=5 Participants
|
|
Ulcer Duration
|
206 days
n=5 Participants
|
228 days
n=7 Participants
|
214 days
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Intent-to-Treat population
Outcome measures
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
n=274 Participants
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Control (Standard-of-Care)
n=263 Participants
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Complete Healing of the Study Ulcer by Week 16.
|
201 participants
|
176 participants
|
SECONDARY outcome
Timeframe: 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.Population: Intent-to-Treat population
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
Outcome measures
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
n=274 Participants
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Control (Standard-of-Care)
n=263 Participants
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Time-to-Complete Healing
|
58 days
Interval 36.0 to 113.0
|
64 days
Interval 36.0 to 113.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Pre-specified Subgroup of the Intent-to-Treat Population
Outcome measures
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
n=198 Participants
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Control (Standard-of-Care)
n=189 Participants
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Complete Healing by Week 16: Ulcers <= 12 Months Duration
|
158 participants
|
132 participants
|
Adverse Events
Investigational Treatment (Dermagraft Plus Standard-of-Care)
Serious events: 28 serious events
Other events: 168 other events
Deaths: 0 deaths
Control (Standard-of-Care)
Serious events: 24 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
n=274 participants at risk
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Control (Standard-of-Care)
n=263 participants at risk
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrilation
|
0.00%
0/274
|
1.1%
3/263 • Number of events 3
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/274
|
0.76%
2/263 • Number of events 2
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
General disorders
Asthenia
|
0.36%
1/274 • Number of events 1
|
0.38%
1/263 • Number of events 1
|
|
General disorders
Death
|
1.1%
3/274 • Number of events 3
|
0.76%
2/263 • Number of events 2
|
|
General disorders
Drug intolerance
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
General disorders
Oedema peripheral
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Abscess
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Infections and infestations
Abscess limb
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Infections and infestations
Appendicitis
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/274
|
0.76%
2/263 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
0.73%
2/274 • Number of events 2
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Clostridial infection
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Infected skin ulcer
|
0.73%
2/274 • Number of events 2
|
0.76%
2/263 • Number of events 2
|
|
Infections and infestations
Laryngitis
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Peritonitis bacterial
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Infections and infestations
Pneumonia
|
0.73%
2/274 • Number of events 2
|
1.1%
3/263 • Number of events 3
|
|
Infections and infestations
Sepsis
|
0.36%
1/274 • Number of events 1
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Injury, poisoning and procedural complications
Facial bones fractures
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Investigations
Angiogram
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Investigations
Cardiac stress test
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.36%
1/274 • Number of events 1
|
0.38%
1/263 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Renal and urinary disorders
Renal failure acute
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pupura
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Surgical and medical procedures
Implantable defibrilator replacement
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Surgical and medical procedures
Therapy regimen changed
|
0.73%
2/274 • Number of events 2
|
0.00%
0/263
|
|
Surgical and medical procedures
Varicose vein operation
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
|
Surgical and medical procedures
Venous operation
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Vascular disorders
Hypertension
|
0.36%
1/274 • Number of events 1
|
0.00%
0/263
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/274
|
0.38%
1/263 • Number of events 1
|
Other adverse events
| Measure |
Investigational Treatment (Dermagraft Plus Standard-of-Care)
n=274 participants at risk
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
|
Control (Standard-of-Care)
n=263 participants at risk
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
28.1%
77/274 • Number of events 77
|
22.8%
60/263 • Number of events 60
|
|
Infections and infestations
Infected skin ulcer
|
8.0%
22/274 • Number of events 22
|
9.5%
25/263 • Number of events 25
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.3%
20/274 • Number of events 20
|
6.1%
16/263 • Number of events 16
|
|
Vascular disorders
Hypertension
|
5.1%
14/274 • Number of events 14
|
4.9%
13/263 • Number of events 13
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
18/274 • Number of events 18
|
6.8%
18/263 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
17/274 • Number of events 17
|
9.5%
25/263 • Number of events 25
|
Additional Information
Mollie Carter, MD, Medical Director
Shire Regenerative Medicine
Phone: (858) 754-5678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Company-specific confidentiality agreement
- Publication restrictions are in place
Restriction type: OTHER