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The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities

Primary Purpose

Chronic Pain, Lower Extremity Wound

Status

Recruiting

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Botulinum Toxin A

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Botulinum toxin A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old.
Lower extremity ulcer ≥ 4 weeks.
Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2
Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4).
Normal monofilament and vibration test in lower extremities.
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.

Exclusion Criteria:

1. Infection at injection site. 2. Hypersensitivity to botulinum toxin A. 3. Peripheral neuropathy. 3. Diabetic foot ulcer. 4. Unstable critic peripheral ischemia judged by investigator 5. Exposed capsule, tendon, muscle or bone in the ulcers. 6. Tunnelling, undermining or sinus tracts. 7. Disorders of the neuromuscular junction (e.g. Myasthenia). 8. Topical analgesic (e.g Biatain ibu or Lidocain) within 7 days before inclusion.

9. Pregnant or lactating woman and woman with childbearing potential but does not use contraception.

10. Judgment by the investigator that the patient is not suited for study participation.

Sites / Locations

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botulinum Toxin A

Arm Description

Open-label study

Outcomes

Primary Outcome Measures

Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41

At study day 0 the mean VAS will be calculated at rest for D-2-0 and at D21 or D41 mean VAS will be calculated for D19-21 or D39-41

Secondary Outcome Measures

Absolute and percentage change in the area of hyperalgesia and allodynia

Area of hyperalgesia and allodynia will be assessed at D0, D21/41 and D90/110

Absolute and percentage change of the ulcer area.

The ulcer size will be measured at every visit with study day 0 as baseline.

Clinical improvement of the wound healing process

Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)

Therapeutic doses of Botulinum toxin a to treat wound pain

Number of patients who need a second injection of Botulinum toxin a on study D21 if mean VAS (D19-21) are similar (± 10 %) to the pre-injection mean VAS at D0

Incidence of Treatment-Emergent Adverse Events

All clinical adverse events will be assessed and recorded.

Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a

Changes in the levels of cytokine and pain related substances will be quantified over time (throughout the trial). Prospects to analyse i.g ( IL-6, NGF, IL-1β) with either MSD,Luminex or ELISA. The results will be expressed as pg/ mg.

Full Information

NCT ID

NCT05426161

First Posted

June 14, 2022

Last Updated

February 8, 2023

Sponsor

Bispebjerg Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05426161

Brief Title

The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities

Official Title

The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities, a Prospective Exploratory Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 7, 2023 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of the study is to investigate the effect of subcutaneous administration of Botulinum toxin A on wound pain, wound healing and safety of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Lower Extremity Wound

Keywords

Botulinum toxin A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

A single-center, prospective, exploratory study

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Botulinum Toxin A

Arm Type

Experimental

Arm Description

Open-label study

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin A

Intervention Description

Botulinum Toxin A (10 units per cm2 wound areal) will be injected subcutaneously around the wound (1-2 cm from wound edge) maximum 200 units at each injection time.The total dose of BoNTA is maximum 400 units. Patient will receive one or two treatments in total.

Primary Outcome Measure Information:

Title

Proportion of patients reaching a reduction in mean visual analog scale (VAS) > 20 mm (at rest) in dynamic pain scores at study day 21 or 41

Description

At study day 0 the mean VAS will be calculated at rest for D-2-0 and at D21 or D41 mean VAS will be calculated for D19-21 or D39-41

Time Frame

3 to 6 weeks after first injection of Botulinum toxin a

Secondary Outcome Measure Information:

Title

Absolute and percentage change in the area of hyperalgesia and allodynia

Description

Area of hyperalgesia and allodynia will be assessed at D0, D21/41 and D90/110

Time Frame

3 to15 weeks after first injection of Botulinum toxin a.

Title

Absolute and percentage change of the ulcer area.

Description

The ulcer size will be measured at every visit with study day 0 as baseline.

Time Frame

Throughout the trial (12-15 weeks)

Title

Clinical improvement of the wound healing process

Description

Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)

Time Frame

Throughout the trial (12-15 weeks)

Title

Therapeutic doses of Botulinum toxin a to treat wound pain

Description

Number of patients who need a second injection of Botulinum toxin a on study D21 if mean VAS (D19-21) are similar (± 10 %) to the pre-injection mean VAS at D0

Time Frame

3 and 6 weeks after first injection

Title

Incidence of Treatment-Emergent Adverse Events

Description

All clinical adverse events will be assessed and recorded.

Time Frame

Throughout the trial (12-15 weeks)

Title

Exploratory measurement: Changes in the levels of cytokines and pain related substances in the wound fluid before and after injection with Botulinum toxin a

Description

Time Frame

Analysis within 1 year after study completion

Other Pre-specified Outcome Measures:

Title

Wound status- Degree of inflammation, granulation tissue, necrosis/slough, exudation and infection.

Description

Semi-quantitatively measured (Absent/Low < 25 %, Mild 25-50 %, Moderate 51-75 %, High > 75%)

Time Frame

Throughout the trial (12-15 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years old. Lower extremity ulcer ≥ 4 weeks. Ulcer area ≥ 1,5 cm2 and ≤ 20 cm2 Patients with neuropathic pain related to the ulcer (daily VAS pain scores ≥ 30 mm at rest and DN4 score ≥ 4). Normal monofilament and vibration test in lower extremities. 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. Exclusion Criteria: 1. Infection at injection site. 2. Hypersensitivity to botulinum toxin A. 3. Peripheral neuropathy. 3. Diabetic foot ulcer. 4. Unstable critic peripheral ischemia judged by investigator 5. Exposed capsule, tendon, muscle or bone in the ulcers. 6. Tunnelling, undermining or sinus tracts. 7. Disorders of the neuromuscular junction (e.g. Myasthenia). 8. Topical analgesic (e.g Biatain ibu or Lidocain) within 7 days before inclusion. 9. Pregnant or lactating woman and woman with childbearing potential but does not use contraception. 10. Judgment by the investigator that the patient is not suited for study participation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lubna Sabah, MD

Phone

+4529466632

lubna.sabah@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Francis Thomsen, Professor

Organizational Affiliation

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital

City

Copenhagen

Country

Denmark

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities

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