Cold IntolerancePhase 1NCT04917731
Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
A Phase 1 study testing Botulinum toxin type A in people with Cold Intolerance, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Intolerance
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 2 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Aim 1: To assess the efficacy of botulinum toxin type A on treating cold intolerance secondary to digital amputations, revascularizations, or replantations
Primary null hypothesis: Randomized subjects who receive botulinum toxin type A injections for pain associated with cold intolerance will experience similar changes in pain as compared to patients randomized to receive saline injections (control)
- As measured by the Cold Insensitivity and Severity Score (CISS) at one week, four weeks, and twelve weeks
Aim 2: To assess the safety of botulinum toxin type A on treating cold intolerance secondary to digital amputations and replantations
Hypothesis: Injection of botulinum toxin for cold intolerance secondary to digital amputations and replantations is not associated with any adverse reactions
III. SUBJECT SELECTION All adult, English-speaking patients who present with cold intolerance secondary to digital amputation or replantation will be approached and asked to participate in the study.
Inclusion criteria 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
Exclusion criteria 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
All patients who satisfy the inclusion/exclusion criteria will be eligible for enrollment. Vulnerable populations will be excluded from this study.
IV. SUBJECT ENROLLMENT A total of twenty-eight patients will be enrolled.
- Conditions
- Cold Intolerance
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox
Botox injected at digital artery
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | The patients in this arm will receive Botox injection to the digital arteries of all affected digits. Receives: 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. Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold Intolerance Severity Score
index of cold intolerance, validated
Measured: 3 months
quick dash
a validated measure of hand function
Measured: three months.
Secondary outcomes (1)
PHQ 9
depression measure, validated
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start2 Jun 2021
- Primary completion2 Jun 2023 (estimated)
- Study completion2 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold IntoleranceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Jonathan M. Winograd, M.D., Massachusetts General Hospital
- Investigators
- Jonathan M Winograd, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917731
- Sponsor's protocol ID
- 2020P002873
- Status last verified
- Aug 2022
- First submitted
- 2 Jun 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
- ClinicalTrials.gov ID
- NCT04917731
- Acronym / sponsor ID
- 2020P002873
- Conditions
- Cold Intolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 2 Jun 2023 (estimated)
- Study completion
- 2 Jun 2023 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim 1: To assess the efficacy of botulinum toxin type A on treating cold intolerance secondary to digital amputations, revascularizations, or replantations
Primary null hypothesis: Randomized subjects who receive botulinum toxin type A injections for pain associated with cold intolerance will experience similar changes in pain as compared to patients randomized to receive saline injections (control)
- As measured by the Cold Insensitivity and Severity Score (CISS) at one week, four weeks, and twelve weeks
Aim 2: To assess the safety of botulinum toxin type A on treating cold intolerance secondary to digital amputations and replantations
Hypothesis: Injection of botulinum toxin for cold intolerance secondary to digital amputations and replantations is not associated with any adverse reactions
III. SUBJECT SELECTION All adult, English-speaking patients who present with cold intolerance secondary to digital amputation or replantation will be approached and asked to participate in the study.
Inclusion criteria 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
Exclusion criteria 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
All patients who satisfy the inclusion/exclusion criteria will be eligible for enrollment. Vulnerable populations will be excluded from this study.
IV. SUBJECT ENROLLMENT A total of twenty-eight patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox | Experimental | Drug: Botulinum toxin type AThe patients in this arm will receive Botox injection to the digital arteries of all affected digits. |
| Placebo | Placebo comparator | Drug: Botulinum toxin type AThe patients in this arm will receive placebo injection of saline to the digital arteries of all affected digits. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Botulinum toxin type AAlso: BotoxBotox injected at digital artery | Drug | Botox, Placebo |
Primary outcome
Cold Intolerance Severity Score
Time frame: 3 months
index of cold intolerance, validated
quick dash
Time frame: three months.
a validated measure of hand function
1 secondary outcome
PHQ 9
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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.
Jonathan M Winograd, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Botulinum toxin type A in people with Cold Intolerance, run by Massachusetts General Hospital at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Cold Intolerance Severity Score (time frame: 3 months). 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?
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 24 Aug 2022; AzTrials last refreshed its copy on 3 Nov 2026.