E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic wound pain and wound healing |
Kronisk sårsmerter og sårheling |
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E.1.1.1 | Medical condition in easily understood language |
chronic wound pain and wound healing |
Kronisk sårsmerter og sårheling |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049542 |
E.1.2 | Term | Wound pain |
E.1.2 | System Organ Class | 100000004863 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of the study is to investigate the effect of subcutaneous administration of Botulinum neurotoxin A on chronic wound pain and wound healing in lower extremity ulcer and safety of the treatment. |
Vi vil gerne undersøge virkningen af subkutan injektion af Botulinum toxine (Botox) på smerter og heling af sår på benene. Samtidig registreres eventuelle bivirkninger ved behandlingen. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age ≥ 18 years old. Lower extremity ulcer ≥ 4 weeks. Ulcer area ≥ 0,5 cm2 and ≤ 20 cm2. VAS pain scores ≥ 30 mm. (Defined as mean VAS ≥ 30 mm in the morning or afternoon at rest or movement measured over 3 consecutive days prior inclusion). Patients with neuropathic pain related to the ulcer (DN4 score ≥ 4). Patients who can fill out pain diary correctly. Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.
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Alder ≥ 18 år. Sår i underekstremitet ≥ 4 uger. Sårareal ≥ 0,5 cm2 og ≤ 20 cm2. VAS smertescore ≥ 30 mm. (Defineret som gennemsnitlig VAS ≥ 30 mm om morgenen eller eftermiddagen i hvile eller bevægelse målt over 3 på hinanden følgende dage før inklusion). Patienter med neuropatisk smerte relateret til såret (DN4 score ≥ 4). Patienter, som kan udfylde smertedagbogen korrekt. Underskrevet skriftligt informeret samtykke til at deltage i undersøgelsen efter at have forstået indholdet af protokollen og begrænsningerne fuldt ud. |
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E.4 | Principal exclusion criteria |
Infection at injection site. Hypersensitivity to botulinum toxin A. Peripheral neuropathy in the area of the wound judged by investigator. Unstable critic peripheral ischemia judged by investigator. Exposed capsule, tendon, muscle or bone in the ulcers. Tunnelling, undermining or sinus tracts. Disorders of the neuromuscular junction (e.g. Myasthenia). Topical analgesic (e.g Biatain ibu or Lidocain) within 4 days before inclusion. Pregnant or lactating woman and woman with childbearing potential but does not use contraception. Judgment by the investigator that the patient is not suited for study participation.
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Infektion på injektionsstedet. Overfølsomhed over for Botox. Perifer nervebetændelse i område omkring såret. Ikke stabil perifer iskæmi vurderet af forsøgsansvarlig læge. Synlig struktur i såret som f.eks. kapsel, sene, muskel eller knogle. Underminering eller fistel. Neuromuskulære forstyrrelser f.eks. Myasthenia gravis. Lokal smertestillende behandling (f.eks. Biatain ibu eller Lidocain) inden for 4 dage før inklusion i forsøget. Gravide og eller ammende kvinder og kvinder i den fertile alder, som ikke bruger prævention. Vurdering af forsøgsansvarlig læge, at patienten ikke er egnet til forsøgsdeltagelse.
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in worst pain assessed on a visual analogue scale (VAS, 0–100 mm) at rest and DN4 questionnaire before and after injection of Botulinum neurotoxin Difference in the area (measured in cm2) of hyperalgesia and allodynia pre- and post-injection of Botulinum neurotoxin. Differences in wound area (measured in cm2) and clinical signs of healing pre- and post-injection of Botulinum neurotoxin Levels of inflammatory cytokines and markers in wound fluid pre- and post-injection of Botulinum neurotoxin. Levels of pain-related substances in wound fluid pre- and post-injection of Botulinum neurotoxin.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of end points will happen during the trial period (about 16 weeks for each patient) and when the laboratory analysis is completed (3-6 months after the end of the trial). |
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E.5.2 | Secondary end point(s) |
Therapeutic doses of Botulinum neurotoxin to treat wound pain. Safety of the treatment.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of end points will happen during the trial period (about 16 weeks for each patient). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |