Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study

NCT04917731 | Unknown Phase 1 FDA Drug

• 1 other identifier: 2020P002873
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be selected for cold intolerance after finger amputation or replantation. They will be given Botox or placebo dose as treatment and assessed over 3 months.

Conditions

Cold Intolerance

Outcome Measures

Primary Outcomes (2)

• Cold Intolerance Severity Score

  index of cold intolerance, validated

  3 months

• quick dash

  a validated measure of hand function

  three months.

Secondary Outcomes (1)

• PHQ 9

  3 months

Study Arms (2)

Botox

EXPERIMENTAL

The patients in this arm will receive Botox injection to the digital arteries of all affected digits.

Drug: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

The patients in this arm will receive placebo injection of saline to the digital arteries of all affected digits.

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

Botox injected at digital artery

Also known as: Botox

Botox; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) diagnosed with cold intolerance secondary to digital amputations, revascularizations, or replantations and a CISS score of 30 or higher (the threshold for pathological cold intolerance)11 Ability to give informed consent

You may not qualify if:

• Adults ≥ 75 years old Inability or unwillingness to participate in CISS or DASH survey Major medical comorbidity expected to worsen in the next 6 months Comorbid chronic pain condition Severe and untreated mental health conditions or active substance dependence Pregnant or breastfeeding Known hypersensitivity to botulinum toxin Patients with a compromised respiratory function Pre-existing neuromuscular disorders Receiving therapy with aminoglycosides, anticholinergic agents, and muscle relaxants Infection in the proposed injection site

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Allergan: collaborator

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Jonathan M Winograd, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Surgeon, Associate Professor Harvard Medical School

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: June 2, 2021
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)