MedDataX Logo

Trial Outcomes & Findings for Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine. (NCT NCT02295020)

NCT ID: NCT02295020

Last Updated: 2016-07-11

Results Overview

Value at 8 weeks - value at day 0

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Week 8- Day 0

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure
Standard Treatment Only.
Group A will receive standard treatment only Standard treatment: Standard treatment such as NSAIDs and injections
Standard Treatment Plus Bioskin Ten-7.
Group B will receive standard treatment and the Bioskin Ten-7 knee brace. Standard treatment: Standard treatment such as NSAIDs and injections Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace
Overall Study
STARTED
20
20
Overall Study
COMPLETED
17
17
Overall Study
NOT COMPLETED
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Standard Treatment Only.
Group A will receive standard treatment only Standard treatment: Standard treatment such as NSAIDs and injections
Standard Treatment Plus Bioskin Ten-7.
Group B will receive standard treatment and the Bioskin Ten-7 knee brace. Standard treatment: Standard treatment such as NSAIDs and injections Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace
Overall Study
Adverse Event
0
1
Overall Study
Withdrawal by Subject
3
2

Baseline Characteristics

Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Treatment Only
n=20 Participants
Standard treatment only such as NSAIDs and injections
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=20 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
57.4 years
STANDARD_DEVIATION 11.3 • n=5 Participants
61.5 years
STANDARD_DEVIATION 8.8 • n=7 Participants
59.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
16 Participants
n=7 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants
Standard of care
Surpatz
2 participants
n=5 Participants
0 participants
n=7 Participants
2 participants
n=5 Participants
Standard of care
NSAID
14 participants
n=5 Participants
4 participants
n=7 Participants
18 participants
n=5 Participants
Standard of care
Medications
4 participants
n=5 Participants
16 participants
n=7 Participants
20 participants
n=5 Participants
Body Mass Index
34.2 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
30.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
32.4 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
KOOS - Pain
37.8 units on a scale
STANDARD_DEVIATION 18.7 • n=5 Participants
33.5 units on a scale
STANDARD_DEVIATION 20.3 • n=7 Participants
35.6 units on a scale
STANDARD_DEVIATION 19.4 • n=5 Participants
KOOS - Symptoms
45.5 units on a scale
STANDARD_DEVIATION 22.4 • n=5 Participants
35.6 units on a scale
STANDARD_DEVIATION 16.7 • n=7 Participants
40.4 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
KOOS - ADL
40.8 units on a scale
STANDARD_DEVIATION 15.6 • n=5 Participants
37.2 units on a scale
STANDARD_DEVIATION 22.2 • n=7 Participants
39.0 units on a scale
STANDARD_DEVIATION 19.1 • n=5 Participants
KOOS - Sport/Rec
29.3 units on a scale
STANDARD_DEVIATION 25.9 • n=5 Participants
12.1 units on a scale
STANDARD_DEVIATION 17.1 • n=7 Participants
19.8 units on a scale
STANDARD_DEVIATION 22.9 • n=5 Participants
KOOS - QOL
28.7 units on a scale
STANDARD_DEVIATION 19.6 • n=5 Participants
14.4 units on a scale
STANDARD_DEVIATION 13.8 • n=7 Participants
20.9 units on a scale
STANDARD_DEVIATION 18.0 • n=5 Participants
IL-6
1639 pg/mL
n=5 Participants
1309 pg/mL
n=7 Participants
1467.1 pg/mL
n=5 Participants
IL-8
653.3 pg/mL
n=5 Participants
486.5 pg/mL
n=7 Participants
643.0 pg/mL
n=5 Participants
TNF-alpha
108.1 pg/mL
n=5 Participants
104.8 pg/mL
n=7 Participants
108.1 pg/mL
n=5 Participants
MIP-1alpha
255.5 pg/mL
n=5 Participants
162.2 pg/mL
n=7 Participants
250.8 pg/mL
n=5 Participants
MCP-1
8664 pg/mL
n=5 Participants
10944 pg/mL
n=7 Participants
10188 pg/mL
n=5 Participants

PRIMARY outcome

Timeframe: Week 8- Day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.

Value at 8 weeks - value at day 0

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=16 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=17 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
KOOS - Pain
17.6 units on a scale
Interval 8.4 to 26.8
9.1 units on a scale
Interval 0.2 to 18.0

PRIMARY outcome

Timeframe: Week 8 - Day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.

Value at 8 weeks - value at day 0

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=16 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=17 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
KOOS - Symptoms
10.6 units on a scale
Interval 1.7 to 19.5
3.2 units on a scale
Interval -5.4 to 11.8

PRIMARY outcome

Timeframe: week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.

Value at 8 weeks - value at day 0

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=16 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=17 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
KOOS - ADL
15.3 units on a scale
Interval 7.4 to 23.2
9.8 units on a scale
Interval 2.1 to 17.4

PRIMARY outcome

Timeframe: Week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.

Value at 8 weeks - value at day 0

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=12 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=12 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
KOOS - Sport/Rec
13.8 units on a scale
Interval -3.5 to 31.0
9.6 units on a scale
Interval -7.6 to 26.8

PRIMARY outcome

Timeframe: Week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.

Value at 8 weeks - value at day 0

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=14 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=16 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
KOOS - QOL
11.0 pg/mL
Interval 0.2 to 21.8
5.4 pg/mL
Interval -4.7 to 15.6

PRIMARY outcome

Timeframe: Week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.

Interleukine 6 in Synovial fluid analysis

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=10 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=11 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Synovial Fluid Analysis (IL-6)
-453.8 pg/mL
Interval -19670.0 to 18168.0
-1055 pg/mL
Interval -7483.0 to 10399.0

PRIMARY outcome

Timeframe: Week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.

Interleukine 8 in Synovial fluid analysis

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=11 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=12 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Synovial Fluid Analysis (IL-8)
-379.8 pg/mL
Interval -2875.0 to 6878.0
-488.9 pg/mL
Interval -3542.0 to 4906.0

PRIMARY outcome

Timeframe: Week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.

Tumor necrosis factor - alpha in Synovial fluid analysis

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=11 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=12 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Synovial Fluid Analysis (TNF-alpha)
-97.4 pg/mL
Interval -242.3 to 172.4
-51.7 pg/mL
Interval -430.0 to 280.9

PRIMARY outcome

Timeframe: Week 8 - day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.

Macrophage Inflammatory Proteins - 1alpha

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=9 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=11 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Synovial Fluid Analysis (MIP - 1alpha)
-246.7 pg/mL
Interval -821.2 to 575.2
-49.8 pg/mL
Interval -756.6 to 1715.0

PRIMARY outcome

Timeframe: Week 8 -day 0

Population: Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.

Monocyte chemotactic protein-1 - 1

Outcome measures

Outcome measures
Measure
Standard Treatment Only
n=11 Participants
Standard treatment only such as NSAIDs and injections.
Standard Treatment Plus Bioskin Ten-7 Knee Brace
n=12 Participants
Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
Synovial Fluid Analysis (MCP - 1)
-7170 pg/mL
Interval -14933.0 to 17960.0
-4890 pg/mL
Interval -15989.0 to 17432.0

PRIMARY outcome

Timeframe: Day 0 and Week 8

Population: The outcome was not measured as KOOS was measured as the only patient reported outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 0 and Week 8

Population: The outcome was not measured as KOOS was measured as the only patient reported outcome.

assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 0 and Week 8

Population: The outcome was not measured as KOOS was measured as the only patient reported outcome.

identifies pain level

Outcome measures

Outcome data not reported

Adverse Events

Group A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group B

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Group A
n=20 participants at risk
Group A will receive standard treatment only Standard treatment: Standard treatment such as NSAIDs and injections
Group B
n=20 participants at risk
Group B will receive standard treatment and the Bioskin Ten-7 knee brace. Standard treatment: Standard treatment such as NSAIDs and injections Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace
Vascular disorders
CVA
0.00%
0/20
5.0%
1/20 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vinod Dasa

LSUHSC-NO -Orthopaedic Department

Phone: (504) 412-1700

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place