Trial Outcomes & Findings for Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers (NCT NCT00796744)
NCT ID: NCT00796744
Last Updated: 2012-09-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Healing to occur within 12 weeks of first treatment
Results posted on
2012-09-27
Participant Flow
Participant milestones
| Measure |
Placebo Vehicle Control
control placebo vehicle
|
0.03 % DSC127
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
28
|
|
Overall Study
COMPLETED
|
24
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
Baseline characteristics by cohort
| Measure |
Placebo Vehicle Control
n=24 Participants
control placebo vehicle
|
0.03 % DSC127
n=26 Participants
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=28 Participants
0.01% DSC127 in Vehicle Control
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age Continuous
|
56.8 years
STANDARD_DEVIATION 12.77 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 10.35 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 12.47 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 11.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
78 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Healing to occur within 12 weeks of first treatmentPopulation: Intent-to-Treat Population
Outcome measures
| Measure |
Placebo
n=24 Participants
control placebo vehicle
|
0.03% DSC127
n=26 Participants
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=27 Participants
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.
|
8 number of ulcers healed
Interval 15.6 to 55.3
|
14 number of ulcers healed
Interval 33.4 to 73.4
|
8 number of ulcers healed
Interval 13.8 to 50.2
|
SECONDARY outcome
Timeframe: Duration of subject's participation (24 weeks)Population: Safety Population
Outcome measures
| Measure |
Placebo
n=24 Participants
control placebo vehicle
|
0.03% DSC127
n=26 Participants
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=28 Participants
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
All Adverse Event
|
23 patients
|
26 patients
|
28 patients
|
|
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Serious Adverse Event
|
5 patients
|
4 patients
|
4 patients
|
|
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Related to Study Drug
|
0 patients
|
0 patients
|
0 patients
|
SECONDARY outcome
Timeframe: 12 weeksThe overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.
Outcome measures
| Measure |
Placebo
n=24 Participants
control placebo vehicle
|
0.03% DSC127
n=26 Participants
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=27 Participants
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
The Rate of Re-epithelialization of the Ulcer Site.
|
10.5 percent ulcer area re-epithelialized/wk
Standard Deviation 21.2
|
14.3 percent ulcer area re-epithelialized/wk
Standard Deviation 12.8
|
9.0 percent ulcer area re-epithelialized/wk
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: 24 weeksAverage time to complete re-epithelialization of baseline ulcer area.
Outcome measures
| Measure |
Placebo
n=24 Participants
control placebo vehicle
|
0.03% DSC127
n=26 Participants
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=27 Participants
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
The Time to Re-epithelialization of the Ulcer Site.
|
16.5 Weeks
Standard Error 1.77
|
12.4 Weeks
Standard Error 1.80
|
17.3 Weeks
Standard Error 1.53
|
Adverse Events
Placebo Vehicle Control
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
0.03 % DSC127
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
0.01% DSC127
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Vehicle Control
n=24 participants at risk
control placebo vehicle
|
0.03 % DSC127
n=26 participants at risk
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=28 participants at risk
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
Cardiac disorders
Acute Myocardial infarction
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
General disorders
Chest Pain
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
7.7%
2/26 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
General disorders
Oedema Peripheral
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Infections and infestations
Cellulitis
|
8.3%
2/24 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Infections and infestations
Osteomyelitis
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
7.1%
2/28 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Nervous system disorders
Syncope
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Surgical and medical procedures
Foot Amputation
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Surgical and medical procedures
Joint Arthroplasty
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Surgical and medical procedures
Spinal Fusion Surgery
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Surgical and medical procedures
Tendon Operation
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
Other adverse events
| Measure |
Placebo Vehicle Control
n=24 participants at risk
control placebo vehicle
|
0.03 % DSC127
n=26 participants at risk
0.03% DSC127 in Vehicle Control
|
0.01% DSC127
n=28 participants at risk
0.01% DSC127 in Vehicle Control
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
7.7%
2/26 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
7.7%
2/26 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Infections and infestations
Diabetic foot infection
|
8.3%
2/24 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
0.00%
0/28 • 24 weeks
Maximum subject participation period.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
7.7%
2/26 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
7.1%
2/28 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
|
Investigations
Blood Glucose Increased
|
4.2%
1/24 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
7.1%
2/28 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
29.2%
7/24 • Number of events 10 • 24 weeks
Maximum subject participation period.
|
26.9%
7/26 • Number of events 10 • 24 weeks
Maximum subject participation period.
|
35.7%
10/28 • Number of events 22 • 24 weeks
Maximum subject participation period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
2/24 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
3.8%
1/26 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.3%
2/24 • Number of events 4 • 24 weeks
Maximum subject participation period.
|
7.7%
2/26 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
17.9%
5/28 • Number of events 7 • 24 weeks
Maximum subject participation period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/24 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
7.1%
2/28 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
7.7%
2/26 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
|
Skin and subcutaneous tissue disorders
Skin Maceration
|
4.2%
1/24 • Number of events 1 • 24 weeks
Maximum subject participation period.
|
11.5%
3/26 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
3.6%
1/28 • Number of events 2 • 24 weeks
Maximum subject participation period.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Number of events 4 • 24 weeks
Maximum subject participation period.
|
0.00%
0/26 • 24 weeks
Maximum subject participation period.
|
7.1%
2/28 • Number of events 3 • 24 weeks
Maximum subject participation period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor prepared an integrated clinical/statistical report. As this was a multicenter study, any publication/presentation of data was to include the entire study population. Publication/presentation of data from individual study centers is not allowed without explicit permission from US Biotest.
- Publication restrictions are in place
Restriction type: OTHER