Clinical Trials Register

Summary
EudraCT Number:	2021-004870-78
Sponsor's Protocol Code Number:	202100625
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-10-04
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2021-004870-78

A.3

Full title of the trial

Detecting mitochondrial oxygen tension (mitoPO2) as a measure of local tissue oxygenation in patients with various stages of PAD with the Cellular Oxygen Metabolism (COMET) measurement system of Photonics Healthcare B.V. - A pilot study

Detectie van mitochondriale zuurstofspanning (mitoPO2) als maat voor lokale weefseloxygenatie bij patiënten met verschillende stadia van PAD met het meetsysteem Cellular Oxygen Metabolism (COMET) van Photonics Healthcare B.V. - Een pilotstudie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Measuring oxygen in skin of patients with peripheral arterial disease with the COMET measurement system

Zuurstof meten in de huid van patiënten met perifeer arterieel vaatlijden met het COMET-meetsysteem

A.3.2

Name or abbreviated title of the trial where available

COMPASION

A.4.1

Sponsor's protocol code number

202100625

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University Medical Centre Groningen
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	University Medical Centre Groningen
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Centre Groningen
B.5.2	Functional name of contact point	Abdallah Kaylani
B.5.3	Address:
B.5.3.1	Street Address	Zaagmuldersweg 1-43
B.5.3.2	Town/ city	Groningen
B.5.3.3	Post code	9713LA
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31687827217
B.5.6	E-mail	a.h.a.zaid.al-kaylani@umcg.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Alacare
D.2.1.1.2	Name of the Marketing Authorisation holder	photonamic GmbH & Co. KG (Theaterstrasse 6, D-22880 Wedel, Germany)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Alacare
D.3.4	Pharmaceutical form	Cutaneous patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Peripheral Arterial disease

Perifere arteriële ziekte

E.1.1.1

Medical condition in easily understood language

Patients who have blockages in the blood supply of one or both of their legs.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to determine the feasibility and safety of mitochondrial oxygenation measurements with the COMET device and Alacare patch in patients with severe claudication (Rutherford class 4-6).

E.2.2

Secondary objectives of the trial

The secondary objective(s) are:
• To determine the optimal measurement location for the measurement of mitochondrial oxygen consumption with the best signal quality.
• To determine the influence of application time for the Alacare patch on the signal quality.
• To correlate the COMET device measurements to TcPO2 and ankle brachial index (ABI), and
• To determine if signal quality drops after measuring in the place of the same Alacare patch spot.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- 55 years and older.
- Written informed consent.
- Claudication, Rutherford class 4-6.

E.4

Principal exclusion criteria

- Insufficient knowledge of the Dutch language, illiteracy, or language barrier.
- Lower leg fracture within the past 12 months.
- (Partial) amputation of one of the feet and/or legs.
- Pregnant or breastfeeding.
- Severe peripheral oedema and/or skin defects.
- Severe cardiac-pulmonary failure.
- Active cellulitis-erysipelas of the legs or other dermatological diseases.
- Known hypersensitivity to the active substance or any of the following excepients: plasters: acrylic pressure sensitive adhesive (poly[(2-ethylhexyl)acrylate-co-methylacrylate-co-acrylic acid-co-glycidylmethacrylate]), backing film: pigmented polyethylene aluminium vapor coated polyester, and release liner (polyethylene terephthalate film) which is removed prior to application.
- Known diagnosis of porphyria.
- Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematoides or phemphigus erythematoides.
- Diabetes.

There will be no exclusion based on skin colour. Previous studies have confirmed that the device works with all skin colours and is not dependent on it.
Patients will be asked if they have any known hypersensitivity.
Photodermatosis has a clear profile. We will check patients’ medical history and will ask all subjects explicitly.
Patients with PAD have more comorbidities, and often suffer from diabetes, cardiac and pulmonary diseases. A major complication of CLTI in combination with diabetes are non-healing ulcers of the lower extremity.

E.5 End points

E.5.1

Primary end point(s)

The main endpoint of this pilot study is the occurrence of itching, irritation/pain, or wounds at the site of the patch, and the feasibility of COMET measurements to determine tissue perfusion in the lower extremity in patients with moderate to severe claudication (Rutherford class 4-6) assessed by display of the measurements on the COMET monitor with sufficient signal quality. The verbal rating scale (VRS)31 will be used to assess itching. It is a 5-point Likert scale in which patients are asked to categorize their pruritus (0= “no itch,” 1= “weak itch,” 2= “moderate itch,” 3= “severe itch”, 4= ”very severe itch”). Irritation, pain, and wounds will be assessed visually and via standardised questionnaires.

E.5.1.1

Timepoint(s) of evaluation of this end point

Patients' safety will be monitored from the second they apply the Alacare until they leave the hospital.

E.5.2

Secondary end point(s)

• Standardized and optimal measurement protocol in terms of location and time in patients with moderate to severe claudication (Rutherford class 4-6) through comparing signal quality at different locations and time points
• COMET measurements in correlation with tcPO2 and ABI.
• Difference in signal quality for the same location under the same Alacare patch at two measurement sessions.

E.5.2.1

Timepoint(s) of evaluation of this end point

After the last measurement from the last patient has been concluded.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Pilot study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

This use of the cream with the COMET device will be compared against ABI and TcPO2

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None.

Geen.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-15

P. End of Trial
P.	End of Trial Status	Ongoing

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