Trial Outcomes & Findings for Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers (NCT NCT00536744)
NCT ID: NCT00536744
Last Updated: 2014-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
206 participants
Primary outcome timeframe
12 weeks post initial application
Results posted on
2014-04-14
Participant Flow
Participant milestones
| Measure |
dermaPACE Application + Standard of Care
dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.
|
Non-energized (Inactive) Application + Standard of Care
Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
99
|
|
Overall Study
COMPLETED
|
78
|
71
|
|
Overall Study
NOT COMPLETED
|
29
|
28
|
Reasons for withdrawal
| Measure |
dermaPACE Application + Standard of Care
dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.
|
Non-energized (Inactive) Application + Standard of Care
Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
10
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
|
Overall Study
PI tried alternative treatment
|
1
|
3
|
Baseline Characteristics
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
dermaPACE Application + Standard of Care
n=107 Participants
dermaPACE: dermaPACE + Standard of care wound dressing.
|
Non-energized (Inactive) Application + Standard of Care
n=99 Participants
Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
94 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post initial applicationPopulation: ITT
Outcome measures
| Measure |
dermaPACE Application + Standard of Care
n=107 Participants
dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.
|
Non-energized (Inactive) Application + Standard of Care
n=99 Participants
Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.
|
|---|---|---|
|
The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application.
|
22 participants
Interval 13.4 to 29.5
|
15 participants
Interval 8.7 to 23.8
|
SECONDARY outcome
Timeframe: 12 weeks post initial application and 24 weeks post initial applicationOutcome measures
Outcome data not reported
Adverse Events
dermaPACE Application + Standard of Care
Serious events: 34 serious events
Other events: 54 other events
Deaths: 0 deaths
Non-energized (Inactive) Application + Standard of Care
Serious events: 37 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
dermaPACE Application + Standard of Care
n=107 participants at risk
dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.
|
Non-energized (Inactive) Application + Standard of Care
n=99 participants at risk
Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.
|
|---|---|---|
|
Infections and infestations
Application site infections
|
15.0%
16/107
|
27.3%
27/99
|
|
Cardiac disorders
MI and cardiac failure
|
5.6%
6/107
|
6.1%
6/99
|
|
Gastrointestinal disorders
GI Haemmorhage
|
1.9%
2/107
|
2.0%
2/99
|
|
General disorders
application site disorders
|
2.8%
3/107
|
1.0%
1/99
|
|
Injury, poisoning and procedural complications
Fall, complication from other procedure
|
0.93%
1/107
|
1.0%
1/99
|
|
Investigations
bacterial test positive
|
0.00%
0/107
|
1.0%
1/99
|
|
Metabolism and nutrition disorders
dehydration and other disease related problems
|
3.7%
4/107
|
1.0%
1/99
|
|
Musculoskeletal and connective tissue disorders
Arthritis and joint pain
|
1.9%
2/107
|
0.00%
0/99
|
|
Nervous system disorders
ischemic attack, syncope
|
1.9%
2/107
|
2.0%
2/99
|
|
Renal and urinary disorders
renal failure
|
1.9%
2/107
|
2.0%
2/99
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.93%
1/107
|
1.0%
1/99
|
|
Skin and subcutaneous tissue disorders
skin necrosis
|
0.00%
0/107
|
1.0%
1/99
|
|
Vascular disorders
diabetic vascular disorder
|
0.93%
1/107
|
1.0%
1/99
|
Other adverse events
| Measure |
dermaPACE Application + Standard of Care
n=107 participants at risk
dermaPACE application + standard of care
dermaPACE: dermaPACE + Standard of care wound dressing.
|
Non-energized (Inactive) Application + Standard of Care
n=99 participants at risk
Non-energized (inactive) application + standard of care
Sham: Sham treatment + Standard of care wound dressing.
|
|---|---|---|
|
Blood and lymphatic system disorders
blood deficiencies
|
2.8%
3/107
|
3.0%
3/99
|
|
Cardiac disorders
cardiac disorders
|
3.7%
4/107
|
1.0%
1/99
|
|
Ear and labyrinth disorders
hearing disorders
|
3.7%
4/107
|
1.0%
1/99
|
|
Eye disorders
eye conditions
|
1.9%
2/107
|
5.1%
5/99
|
|
Gastrointestinal disorders
nausea, stomach discomfort, bowel conditions
|
11.2%
12/107
|
16.2%
16/99
|
|
General disorders
target site pain, irritation, illnesses
|
22.4%
24/107
|
31.3%
31/99
|
|
Immune system disorders
allergies
|
1.9%
2/107
|
1.0%
1/99
|
|
Infections and infestations
infections
|
36.4%
39/107
|
21.2%
21/99
|
|
Injury, poisoning and procedural complications
non-ulcer injuries
|
21.5%
23/107
|
16.2%
16/99
|
|
Investigations
blood tests, weight increase
|
10.3%
11/107
|
16.2%
16/99
|
|
Metabolism and nutrition disorders
anorexia, dehydration, diabetes related conditions
|
26.2%
28/107
|
20.2%
20/99
|
|
Musculoskeletal and connective tissue disorders
joint and muscle pain
|
15.0%
16/107
|
10.1%
10/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin papilloma
|
0.00%
0/107
|
1.0%
1/99
|
|
Nervous system disorders
headache, syncope, dizziness, ischemic attack
|
12.1%
13/107
|
9.1%
9/99
|
|
Psychiatric disorders
anxiety, depression
|
4.7%
5/107
|
3.0%
3/99
|
|
Renal and urinary disorders
renal failure, incontinence
|
2.8%
3/107
|
6.1%
6/99
|
|
Reproductive system and breast disorders
prostatic hypoplasia, vulvovaginal burning
|
1.9%
2/107
|
2.0%
2/99
|
|
Respiratory, thoracic and mediastinal disorders
coughing, congestion
|
7.5%
8/107
|
7.1%
7/99
|
|
Skin and subcutaneous tissue disorders
blisters, dermatitis, non-ulcer skin conditions
|
16.8%
18/107
|
15.2%
15/99
|
|
Vascular disorders
arterial stenosis, DVT, hypertension
|
6.5%
7/107
|
6.1%
6/99
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place