Chronic Ulcer of Lower ExtremityPhase 4NCT06878482
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
A Phase 4 study testing Botulinum toxin A in people with Chronic Ulcer of Lower Extremity and Wound, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of subcutaneous injection of botulinum toxin A on wound healing caused by lower extremity ischemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Ulcer of Lower Extremity, Wound, Botulinum Toxins, Type A
- What is being tested?
- Botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2023to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 20 years old
- Patients who have a lower extremity wound among those who have been diagnosed with moderate or severe lower extremity ischemia
- Patients who are unable to perform additional procedures (angioplasty, etc.) by performing peripheral vascular examination and CT angiography
- Wound size ≥ 1x1cm2 to ≤ 3x3cm2
- Patients who can follow the clinical trial procedure well and abide by the visit schedule
- Written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions.
Who cannot join
- Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, Rinco Those who have taken mycin antibiotics, etc.)
- Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
- Those who have received botulinum toxin preparations within 3 months before screening
- Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
- Cases in which blood flow to the lower extremities can be preserved by performing balloon angioplasty even if all three major blood vessels in the lower extremity are blocked
Show all 12Show fewer
- Those who are currently taking steroids or immunosuppressants that affect wounds, or those who have taken them within one month of screening
- Those who have applied injection drugs or wound coverings that help improve wounds within 1 week of screening
- Women who are pregnant, lactating, planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods (women of childbearing age must be negative in the pregnancy test prior to injection).
- Those who are allergic or sensitive to botulinum toxin
- Those who have participated in another clinical trial within 30 days before screening or those who have not passed the half-life of the investigational product of the clinical trial that they participated in, whichever is longer.
- Those who are not suitable for this clinical trial under the judgment of other investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
Hiisun Jeong, doctor
Hiisun Jeong, doctor
About this study
Official title: Effect of Increasing Blood Flow by Botulinum Toxin Local Injection for Severe Peripheral Artery Occlusive Disease: Preliminary Report
The purpose of this study is to investigate the effect of subcutaneous injection of botulinum toxin A on wound healing caused by lower extremity ischemia.
Read the detailed description
Tissues below the calf are governed by blood flow from the anterior tibial artery, peroneal artery, and posterior tibial artery. When an ulcer occurs due to acute lower extremity ischemia, one of the three blood vessels is blocked by a blood clot, or when the blood vessel is narrowed due to perivascular inflammation, such as Buerger's disease, it occurs in a subacute or chronic form. In particular, in the case of elderly patients with ulcers or diabetic feet due to lower extremity ischemia, the symptoms are often worsened by chronic narrowing of blood vessels due to arteriosclerosis or blockage by blood clots. To treat this, prostaglandin or antithrombotic drugs are taken, and blood flow is resumed through stent surgery, but in the lower extremities, the recurrence rate is relatively high because the blood vessels are smaller than the iliac artery, femoral artery, and popliteal artery.
Botulinum toxin is known to have a positive effect on wound healing and blood flow improvement. Botulinum toxin has been published several times in papers showing its spasmolytic effect by participating in the radiographic hip osteoarthritis Ras homolog A (RhoA)/Rock-assisted protein kinase (ROCK) pathway. In addition, botulinum toxin has a vasodilating effect related to the calcitonin gene-related peptide (CGRP) pathway, and is involved in increasing vascular endothelial growth factor (VEGF) from NO-mediated angiogenesis, inhibiting vasoconstriction, increasing blood flow rate, and promoting angiogenesis.
In this study, in patients with chronic wounds on the feet, whose lower extremity blood vessels circulate mainly through collateral circulation, subcutaneous injection of Botulinum toxin in and around the wound improves blood flow around the wound and confirms the degree of wound healing.
- Being tested
- Botulinum toxin A
- Keywords
- Botulinum Toxins, Type A, Wound, Chronic Ulcer of Lower Extremity, Blood Circulation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
subcutaneous injection of Botulinum toxin A
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A | Experimental | Single group(Botulinum toxin A) Open label Receives: Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tcPO2(mmHg) measurement within the edge of 1cm Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
tcPO2 measurement
Measured: Baseline/7days after IP/14days after IP
Secondary outcomes (2)
Change in color-graded amount(using Thermal Imaging Camera) within Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
color-graded amount(using Thermal Imaging Camera)
Measured: Baseline/7days after IP/14days after IP
Changes in wound quality and area in photographs at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
wound quality and area in photographs(Digital Camera)
Measured: Baseline/7days after IP/14days after IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start17 Apr 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ulcer of Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hii Sun Jeong, Yonsei University
- Investigators
- Hiisun J, Dr, Principal investigator, Yonsei University College of Medicine, Yongin Severance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878482
- Sponsor's protocol ID
- 9-2023-0006
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.
PubMed 27997734
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increasing Blood Flow by Botulinum Toxin Local Injection for Severe Peripheral Artery Occlusive Disease: Preliminary Report
- ClinicalTrials.gov ID
- NCT06878482
- Acronym / sponsor ID
- 9-2023-0006
- Keywords
- Botulinum Toxins, Type A, Wound, Chronic Ulcer of Lower Extremity, Blood Circulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Mar 2025 (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.
The purpose of this study is to investigate the effect of subcutaneous injection of botulinum toxin A on wound healing caused by lower extremity ischemia.
Detailed description
Tissues below the calf are governed by blood flow from the anterior tibial artery, peroneal artery, and posterior tibial artery. When an ulcer occurs due to acute lower extremity ischemia, one of the three blood vessels is blocked by a blood clot, or when the blood vessel is narrowed due to perivascular inflammation, such as Buerger's disease, it occurs in a subacute or chronic form. In particular, in the case of elderly patients with ulcers or diabetic feet due to lower extremity ischemia, the symptoms are often worsened by chronic narrowing of blood vessels due to arteriosclerosis or blockage by blood clots. To treat this, prostaglandin or antithrombotic drugs are taken, and blood flow is resumed through stent surgery, but in the lower extremities, the recurrence rate is relatively high because the blood vessels are smaller than the iliac artery, femoral artery, and popliteal artery.
Botulinum toxin is known to have a positive effect on wound healing and blood flow improvement. Botulinum toxin has been published several times in papers showing its spasmolytic effect by participating in the radiographic hip osteoarthritis Ras homolog A (RhoA)/Rock-assisted protein kinase (ROCK) pathway. In addition, botulinum toxin has a vasodilating effect related to the calcitonin gene-related peptide (CGRP) pathway, and is involved in increasing vascular endothelial growth factor (VEGF) from NO-mediated angiogenesis, inhibiting vasoconstriction, increasing blood flow rate, and promoting angiogenesis.
In this study, in patients with chronic wounds on the feet, whose lower extremity blood vessels circulate mainly through collateral circulation, subcutaneous injection of Botulinum toxin in and around the wound improves blood flow around the wound and confirms the degree of wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Experimental | Drug: Botulinum toxin ASingle group(Botulinum toxin A) Open label |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 20 years old
- Patients who have a lower extremity wound among those who have been diagnosed with moderate or severe lower extremity ischemia
- Patients who are unable to perform additional procedures (angioplasty, etc.) by performing peripheral vascular examination and CT angiography
- Wound size ≥ 1x1cm2 to ≤ 3x3cm2
- Patients who can follow the clinical trial procedure well and abide by the visit schedule
Key exclusion criteria (12 listed)
- Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
- Within 4 weeks before screening, aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants, anticholinergics, benzodiazepines, benzamides, tetracyclines, Rinco Those who have taken mycin antibiotics, etc.)
- Those taking aspirin, NSAIDs or anticoagulants within 7 days before screening
- Those who have received botulinum toxin preparations within 3 months before screening
- Angiography or CT angiography If one or more of the three major blood vessels in the lower extremity are open
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 Asubcutaneous injection of Botulinum toxin A | Drug | Botulinum toxin A |
Primary outcome
Change in tcPO2(mmHg) measurement within the edge of 1cm Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
Time frame: Baseline/7days after IP/14days after IP
tcPO2 measurement
2 secondary outcomes
Change in color-graded amount(using Thermal Imaging Camera) within Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
Time frame: Baseline/7days after IP/14days after IP
Changes in wound quality and area in photographs at 7 days and 14 days after IP compared to baseline(Pre-administration IP)
Time frame: Baseline/7days after IP/14days after IP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Results publication: PubMed 27997734Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.
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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.
Hiisun J, Dr principal investigator
Yonsei University College of Medicine, Yongin Severance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin A in people with Chronic Ulcer of Lower Extremity and Wound, run by Yonsei University at 1 site in South Korea.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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 South Korea. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hiisun J, Dr (823151899730, hsjeongps@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tcPO2(mmHg) measurement within the edge of 1cm Diabetic foot wound at 7 days and 14 days after IP compared to baseline(Pre-administration IP) (time frame: Baseline/7days after IP/14days after IP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878482, which also lists 1 linked publication.
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 17 Mar 2025.