Wound Healing DisorderNCT03720119

Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®

An observational study of Wound Healing Disorder, run by SOFAR S.p.A. at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound Healing Disorder
What is being tested?: Lidocaine Hydrochloride
How many people: 78 participants
Where: 2 sitesItaly
Study dates: 27 Jan 2015to 5 Mar 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: A sample size of 70 evaluable patients is needed to test the hypothesis of an improvement in wound pain relief and a reduction in pain intensity, assuming a standardized effect size equal to 0.35, for a one-tailed test with a 5% significance level and a 90% power. A 10% of attrition rate is expected; therefore, a total number of patients to be enrolled is 78.

Who may be able to join

Age >18 years
Patients with painful exuding wounds >1 cm2 that includes painful exuding ulcers and pressure ulcers grade II [according to National Pressure Ulcer Advisory Panel (NPUAP) classification]
Patients available and able to return to the study site for the scheduled visits
Patients who gave written informed consent to take part into the study

Who cannot join

Patients with ulcer infected, discoloured, odorous, pressure ulcer grade I, III, or IV (according to NPUAP classification)
Diabetic foot ulcer
Patients with contraindication or known allergy to drug's components
Patients with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies
Patients who are pregnant or lactating.
Patients with vascular disorders (mainly arteriopathies)
Patients known as alcohol or drug abusers.
Patients currently participating in a clinical study

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Azienda Ospedaliero Pisana
Pisa
Ospedali Riuniti Trieste
Trieste

Other trials in Italy

About this study

Acute pain may occur due to trauma, surgery, infection, disruption of blood circulation or when there is tissue injury. It can be managed using analgesics and conduction anaesthesia, which may be preferable because of superior pain control and fewer side effects. Lidocaine hydrochloride is used topically to relieve itching, burning and pain from skin inflammation. This multicentric observational study is aimed to evaluate the relief gained with lidocaine hydrochloride (ORTODERMINA®) on wound pain in patients with painful wounds and to collect safety information on this treatment.

Read the detailed description

Acute pain can be managed using analgesics and conduction anaesthesia which may be preferable because of superior pain control and fewer side effects. In this contest, lidocaine hydrochloride (ORTODERMINA®) plays an important role in pain management during wound healing. The properties of ORTODERMINA® and its ability to maintain an adequate level of active drug over the lesion allow a persistent anaesthetic effect. ORTODERMINA® is a drug for topical application in the form of cream, with a high safety profile. However, although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anaesthetic agent administered.

This multicentric observational study is aimed to evaluate the relief gained with ORTODERMINA® on wound pain in patients with painful wounds and to collect safety information on this treatment.

Conditions: Wound Healing Disorder
Being tested: Lidocaine Hydrochloride
Keywords: wound healing, pain, lidocaine
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine HydrochlorideDrug
Also called ORTODERMINA®
As per clinical practice, a local treatment with ORTODERMINA® over a 14-day period (once a day) was prescribed. ORTODERMINA® contains 5% of lidocaine hydrochloride.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
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.
Measured: Every day for 15 days
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
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.
Measured: Every day for 15 days

Secondary outcomes (1)

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study
Measured: 15 days, starting from informed consent signature up to the end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 20155 Mar 2018

First posted25 Oct 2018
Study start27 Jan 2015
Primary completion5 Mar 2018
Study completion5 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03720119
Sponsor's protocol ID: SINALGO
Status last verified: Oct 2019
First submitted: 15 Oct 2018
Last updated: 12 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. doi: 10.1111/1523-1747.ep12388556.
PubMed 8006433
Dallam L, Smyth C, Jackson BS, Krinsky R, O'Dell C, Rooney J, Badillo C, Amella E, Ferrara L, Freeman K. Pressure ulcer pain: assessment and quantification. J Wound Ostomy Continence Nurs. 1995 Sep;22(5):211-5; discussion 217-8. doi: 10.1097/00152192-199509000-00007.
PubMed 7550776
Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
PubMed 23388350
Chase SK, Melloni M, Savage A. A forever healing: the lived experience of venous ulcer disease. J Vasc Nurs. 1997 Jun;15(2):73-8. doi: 10.1016/s1062-0303(97)90004-2.
PubMed 9238945
Briggs M, Closs SJ. Patients' perceptions of the impact of treatments and products on their experience of leg ulcer pain. J Wound Care. 2006 Sep;15(8):333-7. doi: 10.12968/jowc.2006.15.8.26941.
PubMed 17001939
Khaliq W, Alam S, Puri N. Topical lidocaine for the treatment of postherpetic neuralgia. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004846. doi: 10.1002/14651858.CD004846.pub2.
PubMed 17443559
Santiago S, Ferrer T, Espinosa ML. Neurophysiological studies of thin myelinated (A delta) and unmyelinated (C) fibers: application to peripheral neuropathies. Neurophysiol Clin. 2000 Feb;30(1):27-42. doi: 10.1016/S0987-7053(00)88865-6.
PubMed 10740794
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728
Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation. Control Clin Trials. 1997 Dec;18(6):530-45; discussion 546-9. doi: 10.1016/s0197-2456(97)00008-1.
PubMed 9408716

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Wound Healing Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
ClinicalTrials.gov ID: NCT03720119
Acronym / sponsor ID: SINALGO
Conditions: Wound Healing Disorder
Keywords: wound healing, pain, lidocaine
Study type: Observational
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: SOFAR S.p.A.Industry (pharma, biotech, devices)
Study start: 27 Jan 2015 (actual)
Primary completion: 5 Mar 2018 (actual)
Study completion: 5 Mar 2018 (actual)
First posted: 25 Oct 2018 (actual)
Results: Posted 7 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This multicentric observational study is aimed to evaluate the relief gained with ORTODERMINA® on wound pain in patients with painful wounds and to collect safety information on this treatment.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: A sample size of 70 evaluable patients is needed to test the hypothesis of an improvement in wound pain relief and a reduction in pain intensity, assuming a standardized effect size equal to 0.35, for a one-tailed test with a 5% significance level and a 90% power. A 10% of attrition rate is expected; therefore, a total number of patients to be enrolled is 78.

Key inclusion criteria (4 listed)

Age >18 years
Patients with painful exuding wounds >1 cm2 that includes painful exuding ulcers and pressure ulcers grade II [according to National Pressure Ulcer Advisory Panel (NPUAP) classification]
Patients available and able to return to the study site for the scheduled visits
Patients who gave written informed consent to take part into the study

Key exclusion criteria (8 listed)

Patients with ulcer infected, discoloured, odorous, pressure ulcer grade I, III, or IV (according to NPUAP classification)
Diabetic foot ulcer
Patients with contraindication or known allergy to drug's components
Patients with known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies
Patients who are pregnant or lactating.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lidocaine HydrochlorideAlso: ORTODERMINA®As per clinical practice, a local treatment with ORTODERMINA® over a 14-day period (once a day) was prescribed. ORTODERMINA® contains 5% of lidocaine hydrochloride.	Drug	–

Primary outcome

Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)
Time frame: Every day for 15 days
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.
Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)
Time frame: Every day for 15 days
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.

1 secondary outcome

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 15 days, starting from informed consent signature up to the end of the study

Results and safety

Results posted to the registry on 7 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Cohort	78	69

Primary outcome: Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)

Time frame: Every day for 15 days. Count of participants. Unit: Participants

Measure	Single Cohort n = 78
Day 2: None relief	3
Day 2: Mild	23
Day 2: Moderate	28
Day 2: A lot	20
Day 2: Complete relief	3
Day 3: None relief	2
Day 3: Mild	24
Day 3: Moderate	30

Population analysed: There are missing data in some time-points

Primary outcome: Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)

Time frame: Every day for 15 days. Mean (Standard Deviation). Unit: Score on a scale

Measure	Single Cohort n = 78
NPRS score of Day 1	6.7 (1.90)
NPRS score of Day 2	5.4 (1.91)
NPRS score of Day 3	5.0 (2.09)
NPRS score of Day 4	4.7 (2.17)
NPRS score of Day 5	4.1 (2.16)
NPRS score of Day 6	3.9 (2.2)
NPRS score of Day 7	3.6 (2.05)
NPRS score of Day 8	3.6 (2.22)

Single Cohort: day effect F: 27.83, p = 0.0001, Dunnett's post-hoc test

Population analysed: The degree of pain intensity was recorded by patients on daily diary and revised by Investigators at final visit.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 15 days, from informed consent signature to the end of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Cohort	0 of 78 (0%)	13 of 78 (16.7%)	0 of 78

Limitations and caveats (from the sponsor): There are not limitations or caveats to be reported for this clinical investigation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8006433Phillips TJ. Chronic cutaneous ulcers: etiology and epidemiology. J Invest Dermatol. 1994 Jun;102(6):38S-41S. doi: 10.1111/1523-1747.ep12388556.
Background: PubMed 7550776Dallam L, Smyth C, Jackson BS, Krinsky R, O'Dell C, Rooney J, Badillo C, Amella E, Ferrara L, Freeman K. Pressure ulcer pain: assessment and quantification. J Wound Ostomy Continence Nurs. 1995 Sep;22(5):211-5; discussion 217-8. doi: 10.1097/00152192-199509000-00007.
Background: PubMed 23388350Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
Background: PubMed 9238945Chase SK, Melloni M, Savage A. A forever healing: the lived experience of venous ulcer disease. J Vasc Nurs. 1997 Jun;15(2):73-8. doi: 10.1016/s1062-0303(97)90004-2.
Background: PubMed 17001939Briggs M, Closs SJ. Patients' perceptions of the impact of treatments and products on their experience of leg ulcer pain. J Wound Care. 2006 Sep;15(8):333-7. doi: 10.12968/jowc.2006.15.8.26941.
Background: PubMed 17443559Khaliq W, Alam S, Puri N. Topical lidocaine for the treatment of postherpetic neuralgia. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004846. doi: 10.1002/14651858.CD004846.pub2.
Background: PubMed 10740794Santiago S, Ferrer T, Espinosa ML. Neurophysiological studies of thin myelinated (A delta) and unmyelinated (C) fibers: application to peripheral neuropathies. Neurophysiol Clin. 2000 Feb;30(1):27-42. doi: 10.1016/S0987-7053(00)88865-6.
Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Background: PubMed 9408716Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation. Control Clin Trials. 1997 Dec;18(6):530-45; discussion 546-9. doi: 10.1016/s0197-2456(97)00008-1.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco Romanelli, MD principal investigator

Azienda Ospedaliero, Universitaria Pisana

Elia Ricci, MD study chair

Clinica San Luca, Torino

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Wound Healing Disorder, run by SOFAR S.p.A. at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS) (time frame: Every day for 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03720119, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.