Trial Outcomes & Findings for Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA® (NCT NCT03720119)
NCT ID: NCT03720119
Last Updated: 2023-04-12
Results Overview
The evaluation of wound pain relief was based on a 5-point Visual Rating Scale (0 = none improvement; 4 = total relief). Patients recorded the VRS score every day of treatment in their diary. The improvement in the pain relief was defined as a VRS scores at end of treatment significantly greater than 0.
Recruitment status
COMPLETED
Target enrollment
78 participants
Primary outcome timeframe
Every day for 15 days
Results posted on
2023-04-12
Participant Flow
Patients were recruited from January 27, 2015 to March 05, 2018 in three Italian hospitals in Pisa and Trieste
Participant milestones
| Measure |
Single Cohort
A single cohort of 78 patients with painful wounds \>1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
Baseline characteristics by cohort
| Measure |
Single Cohort
n=78 Participants
A single cohort of 78 patients with painful wounds \>1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
|
|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 21.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Type of wounds
Traumatic
|
39 Participants
n=5 Participants
|
|
Type of wounds
Pathological
|
31 Participants
n=5 Participants
|
|
Type of wounds
Surgical
|
7 Participants
n=5 Participants
|
|
Type of wounds
Geriatric
|
1 Participants
n=5 Participants
|
|
Size of wounds
Width
|
5.99 cm
STANDARD_DEVIATION 5.13 • n=5 Participants
|
|
Size of wounds
Length
|
4.76 cm
STANDARD_DEVIATION 3.35 • n=5 Participants
|
|
Size of wounds
Depth
|
0.29 cm
STANDARD_DEVIATION 0.29 • n=5 Participants
|
|
Presence of exudate
Present
|
53 Participants
n=5 Participants
|
|
Presence of exudate
Not present
|
23 Participants
n=5 Participants
|
|
Presence of exudate
Not defined
|
2 Participants
n=5 Participants
|
|
Odour of wounds
Absent
|
78 Participants
n=5 Participants
|
|
Odour of wounds
Present
|
0 Participants
n=5 Participants
|
|
Edges of wounds
Regular
|
40 Participants
n=5 Participants
|
|
Edges of wounds
Irregular
|
18 Participants
n=5 Participants
|
|
Edges of wounds
Reactive
|
11 Participants
n=5 Participants
|
|
Edges of wounds
Herythematous
|
6 Participants
n=5 Participants
|
|
Edges of wounds
Not defined
|
3 Participants
n=5 Participants
|
|
Colour of wounds
Pink/red/yellow
|
68 Participants
n=5 Participants
|
|
Colour of wounds
Not defined
|
10 Participants
n=5 Participants
|
|
Wounds classification
NPUAP Grade II
|
60 Participants
n=5 Participants
|
|
Wounds classification
Not available
|
18 Participants
n=5 Participants
|
|
Concomitant Therapies
1 therapy
|
19 Participants
n=5 Participants
|
|
Concomitant Therapies
2-4 therapies
|
25 Participants
n=5 Participants
|
|
Concomitant Therapies
>4 therapies
|
6 Participants
n=5 Participants
|
|
Concomitant Therapies
No therapy
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every day for 15 daysPopulation: There are missing data in some time-points
The evaluation of wound pain relief was based on a 5-point Visual Rating Scale (0 = none improvement; 4 = total relief). Patients recorded the VRS score every day of treatment in their diary. The improvement in the pain relief was defined as a VRS scores at end of treatment significantly greater than 0.
Outcome measures
| Measure |
Single Cohort
n=78 Participants
A single cohort of 78 patients with painful wounds \>1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
|
|---|---|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 4 · None relief
|
3 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 4 · Mild
|
24 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 4 · Moderate
|
31 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 4 · A lot
|
15 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 4 · Complete relief
|
4 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 5 · None relief
|
5 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 5 · Mild
|
17 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 5 · Moderate
|
39 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 5 · A lot
|
11 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 5 · Complete relief
|
4 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 6 · None relief
|
6 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 6 · Mild
|
21 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 6 · Moderate
|
33 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 6 · A lot
|
9 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 6 · Complete relief
|
4 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 7 · None relief
|
5 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 7 · Mild
|
16 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 7 · Moderate
|
35 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 7 · A lot
|
9 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 7 · Complete relief
|
5 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 8 · None relief
|
7 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 8 · Mild
|
18 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 8 · Moderate
|
25 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 8 · A lot
|
15 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 8 · Complete relief
|
5 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 9 · None relief
|
5 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 9 · Mild
|
22 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 9 · Moderate
|
22 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 9 · A lot
|
14 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 9 · Complete relief
|
3 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 10 · None relief
|
10 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 10 · Mild
|
16 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 10 · Moderate
|
22 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 10 · A lot
|
16 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 10 · Complete relief
|
3 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 11 · None relief
|
10 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 11 · Mild
|
16 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 11 · Moderate
|
20 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 11 · A lot
|
14 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 11 · Complete relief
|
4 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 12 · None relief
|
12 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 12 · Mild
|
14 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 12 · Moderate
|
20 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 12 · A lot
|
14 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 12 · Complete relief
|
5 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 13 · None relief
|
16 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 13 · Mild
|
10 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 13 · Moderate
|
20 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 13 · A lot
|
14 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 13 · Complete relief
|
4 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 14 · None relief
|
14 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 14 · Mild
|
11 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 14 · Moderate
|
20 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 14 · A lot
|
12 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 14 · Complete relief
|
3 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 15 · None relief
|
13 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 15 · Mild
|
13 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 15 · Moderate
|
15 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 15 · A lot
|
13 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 15 · Complete relief
|
4 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 2 · None relief
|
3 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 2 · Mild
|
23 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 2 · Moderate
|
28 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 2 · A lot
|
20 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 2 · Complete relief
|
3 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 3 · None relief
|
2 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 3 · Mild
|
24 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 3 · Moderate
|
30 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 3 · A lot
|
18 Participants
|
|
Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Day 3 · Complete relief
|
2 Participants
|
PRIMARY outcome
Timeframe: Every day for 15 daysPopulation: The degree of pain intensity was recorded by patients on daily diary and revised by Investigators at final visit.
The evaluation of the pain intensity was based on a 11-point Numerical Pain Rating Scale (NPRS score from 0= no pain to 10= the most intense pain imaginable). Patients recorded the NPRS score every day of treatment in their diary. The improvement in the pain intensity is defined as a decrease in NPRS scores from baseline to the end of treatment.
Outcome measures
| Measure |
Single Cohort
n=78 Participants
A single cohort of 78 patients with painful wounds \>1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
|
|---|---|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 1
|
6.7 Score on a scale
Standard Deviation 1.90
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 2
|
5.4 Score on a scale
Standard Deviation 1.91
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 3
|
5.0 Score on a scale
Standard Deviation 2.09
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 4
|
4.7 Score on a scale
Standard Deviation 2.17
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 5
|
4.1 Score on a scale
Standard Deviation 2.16
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 6
|
3.9 Score on a scale
Standard Deviation 2.2
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 7
|
3.6 Score on a scale
Standard Deviation 2.05
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 8
|
3.6 Score on a scale
Standard Deviation 2.22
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 9
|
3.6 Score on a scale
Standard Deviation 2.22
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 10
|
3.4 Score on a scale
Standard Deviation 2.28
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 11
|
3.2 Score on a scale
Standard Deviation 2.40
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 12
|
3.2 Score on a scale
Standard Deviation 2.40
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 13
|
3.3 Score on a scale
Standard Deviation 2.48
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 14
|
3.0 Score on a scale
Standard Deviation 2.27
|
|
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
NPRS score of Day 15
|
2.8 Score on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: 15 days, starting from informed consent signature up to the end of the studyEvaluation of incidence and severity of AEs and SAEs in all patients entered in the study
Outcome measures
| Measure |
Single Cohort
n=78 Participants
A single cohort of 78 patients with painful wounds \>1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
|
|---|---|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
0 adverse event
|
65 Participants
|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
1 adverse event
|
8 Participants
|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
2 adverse events
|
1 Participants
|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
3 adverse events
|
2 Participants
|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
4 adverse events
|
1 Participants
|
|
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
5 adverse events
|
1 Participants
|
Adverse Events
Single Cohort
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Cohort
n=78 participants at risk
A single cohort of 78 patients with painful wounds \>1 cm2 -painful ulcers and pressure ulcers grade II, per NPUAP classification-, both sexes, aged ≥18 years. Patients were treated with Ortodermina, as per clinical practice. Three investigational sites have been involved.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
3.8%
3/78 • Number of events 6 • 15 days, from informed consent signature to the end of the study
|
|
Infections and infestations
Infection
|
3.8%
3/78 • Number of events 4 • 15 days, from informed consent signature to the end of the study
|
|
Injury, poisoning and procedural complications
BURNING SENSATION
|
1.3%
1/78 • Number of events 4 • 15 days, from informed consent signature to the end of the study
|
|
Gastrointestinal disorders
Stomach Ache
|
1.3%
1/78 • Number of events 1 • 15 days, from informed consent signature to the end of the study
|
|
General disorders
Pain
|
3.8%
3/78 • Number of events 3 • 15 days, from informed consent signature to the end of the study
|
|
Infections and infestations
PYODERMA GANGRENOSUM
|
1.3%
1/78 • Number of events 1 • 15 days, from informed consent signature to the end of the study
|
|
Infections and infestations
COUGH
|
1.3%
1/78 • Number of events 2 • 15 days, from informed consent signature to the end of the study
|
|
Injury, poisoning and procedural complications
ACCIDENTAL FALL WITH FACIAL TRAUMA
|
1.3%
1/78 • Number of events 1 • 15 days, from informed consent signature to the end of the study
|
|
General disorders
FEVER
|
1.3%
1/78 • Number of events 1 • 15 days, from informed consent signature to the end of the study
|
|
Gastrointestinal disorders
Heartburn
|
1.3%
1/78 • Number of events 1 • 15 days, from informed consent signature to the end of the study
|
|
Injury, poisoning and procedural complications
Wound Pain
|
1.3%
1/78 • Number of events 1 • 15 days, from informed consent signature to the end of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place