Chronic Venous DiseasePhase 3NCT04310280
Effects of Local Insulin on Varicose Ulcers for Wound Healing
A Phase 3 study testing Insulin Glargine and Saline in people with Chronic Venous Disease and Varicose Ulcer, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
Trial summary
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Venous Disease, Varicose Ulcer, Wound Healing
- What is being tested?
- Insulin Glargine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2019to 15 Feb 2020
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any gender
- Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
- Absence of infection
Who cannot join
- Presence of diabetes or glycated hemoglobin >6.5%
- Comorbidities that affect wound healing
- Malnutrition
- Active smoking
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Mario Aurelio Martínez-Jiménez
San Luis Potosí City, San Luis Potosí, 78220
About this study
Official title: Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.
Read the detailed description
A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study. A split-mouth model is used.
The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.
- Conditions
- Chronic Venous Disease, Varicose Ulcer, Wound Healing, Insulin, Angiogenesis
- Being tested
- Insulin Glargine, Saline
- Keywords
- Varicose Ulcer, Wound Healing, Insulin, Angiogenesis
- Medical subject headings
- Varicose Ulcer, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
Half of the wound surface is injected daily with topical glargine insulin
SalineDrug
Half of the wound surface is injected daily with topical saline solution
| Study group | Role | What they receive |
|---|---|---|
| Topical insulin glargine | Experimental | The wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized. Receives: Drug: Insulin Glargine |
| 0.9% saline solution | Placebo comparator | The wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final angiogenesis
Number of blood vessels in a skin biopsy
Measured: Day 7
Secondary outcomes (3)
Fibroplasia
Percentage of fibrous tissue in a skin biopsy
Measured: Day 7
Thermal asymmetry
Difference between the temperature of the wound and the surrounding healthy tissue
Measured: Day 7
Hypoglycaemia
Presence of capillary blood glucose of <60 mg/dl or clinical symptoms of hypoglycemia
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment Randomized split-plot design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO AURELIO MARTÍNEZ-JIMÉNEZ, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Jose L Ramirez-GarciaLuna, MD, PhD, Study chair, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310280
- Sponsor's protocol ID
- 01-17
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be available upon request after the publication of results.
Publications
Martinez-Jimenez MA, Valadez-Castillo FJ, Aguilar-Garcia J, Ramirez-GarciaLuna JL, Gaitan-Gaona FI, Pierdant-Perez M, Valdes-Rodriguez R, Sanchez-Aguilar JM. Effects of Local Use of Insulin on Wound Healing in Non-diabetic Patients. Plast Surg (Oakv). 2018 May;26(2):75-79. doi: 10.1177/2292550317740688. Epub 2017 Nov 22.
PubMed 29845043Martinez-Jimenez MA, Aguilar-Garcia J, Valdes-Rodriguez R, Metlich-Medlich MA, Dietsch LJP, Gaitan-Gaona FI, Kolosovas-Machuca ES, Gonzalez FJ, Sanchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angiogenesis. Plast Reconstr Surg. 2013 Dec;132(6):1015e-1019e. doi: 10.1097/PRS.0b013e3182a806f0.
PubMed 24281606Martinez-Jimenez MA, Kolosovas-Machuca S, Alcocer F, Ortiz-Dosal LC, Gonzalez-Grijalva MC, Delsol-Revuelta GA, Gaitan-Gaona FI, Valadez-Castillo FJ, Ramirez-GarciaLuna JL. A Randomized Controlled Trial on the Effect of Local Insulin Glargine on Venous Ulcer Healing. J Surg Res. 2022 Nov;279:657-665. doi: 10.1016/j.jss.2022.06.070. Epub 2022 Aug 3.
PubMed 35932720
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Insulin on Wound Angiogenesis and Fibroplasia in Varicose Ulcers
- ClinicalTrials.gov ID
- NCT04310280
- Acronym / sponsor ID
- 01-17
- Conditions
- Chronic Venous Disease, Varicose Ulcer, Wound Healing, Insulin, Angiogenesis
- Keywords
- Varicose Ulcer, Wound Healing, Insulin, Angiogenesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 17 Mar 2020 (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.
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia is evaluated as the main outcome.
Detailed description
A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria are included in the present study. A split-mouth model is used.
The ulcer is divided into two (sides A and B). The side in which treatment is applied is randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is applied. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and 7, as control of the local temperature of the wound. This is to asses the process of healing and to correlate with our outcome measures. The number of blood vessels will be evaluated as the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment Randomized split-plot design
| Arm | Type | Receives |
|---|---|---|
| Topical insulin glargine | Experimental | Drug: Insulin GlargineThe wound surface is treated locally with glargine insulin injected sub-dermal in a daily matter for 7 days. Allocation is randomized. |
| 0.9% saline solution | Placebo comparator | Drug: SalineThe wound surface is treated with conventional wound care in a daily matter for 7 days. Allocation is randomized. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any gender
- Presence of varicose ulcer in lower extremities with a size greater than 25 cm2
- Absence of infection
Key exclusion criteria (4 listed)
- Presence of diabetes or glycated hemoglobin >6.5%
- Comorbidities that affect wound healing
- Malnutrition
- Active smoking
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 |
|---|---|---|
| Insulin GlargineHalf of the wound surface is injected daily with topical glargine insulin | Drug | Topical insulin glargine |
| SalineHalf of the wound surface is injected daily with topical saline solution | Drug | 0.9% saline solution |
Primary outcome
Final angiogenesis
Time frame: Day 7
Number of blood vessels in a skin biopsy
3 secondary outcomes
Fibroplasia
Time frame: Day 7
Thermal asymmetry
Time frame: Day 7
Hypoglycaemia
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Results publication: PubMed 29845043Martinez-Jimenez MA, Valadez-Castillo FJ, Aguilar-Garcia J, Ramirez-GarciaLuna JL, Gaitan-Gaona FI, Pierdant-Perez M, Valdes-Rodriguez R, Sanchez-Aguilar JM. Effects of Local Use of Insulin on Wound Healing in Non-diabetic Patients. Plast Surg (Oakv). 2018 May;26(2):75-79. doi: 10.1177/2292550317740688. Epub 2017 Nov 22.
- Results publication: PubMed 24281606Martinez-Jimenez MA, Aguilar-Garcia J, Valdes-Rodriguez R, Metlich-Medlich MA, Dietsch LJP, Gaitan-Gaona FI, Kolosovas-Machuca ES, Gonzalez FJ, Sanchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angiogenesis. Plast Reconstr Surg. 2013 Dec;132(6):1015e-1019e. doi: 10.1097/PRS.0b013e3182a806f0.
- Derived from this study: PubMed 35932720Martinez-Jimenez MA, Kolosovas-Machuca S, Alcocer F, Ortiz-Dosal LC, Gonzalez-Grijalva MC, Delsol-Revuelta GA, Gaitan-Gaona FI, Valadez-Castillo FJ, Ramirez-GarciaLuna JL. A Randomized Controlled Trial on the Effect of Local Insulin Glargine on Venous Ulcer Healing. J Surg Res. 2022 Nov;279:657-665. doi: 10.1016/j.jss.2022.06.070. Epub 2022 Aug 3.
- Individual participant dataSharing planned: No. Anonymized data will be available upon request after the publication of results.
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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. This study is not recruiting at the moment.
Jose L Ramirez-GarciaLuna, MD, PhD study chair
Universidad Autonoma de San Luis Potosí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine and Saline in people with Chronic Venous Disease and Varicose Ulcer, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2020. 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 Mexico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Final angiogenesis (time frame: Day 7). 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 NCT04310280, which also lists 3 linked publications.
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 2020.