AngiogenesisPhase 3NCT02396888
Effects of Local Insulin on Wound Angiogenesis
A Phase 3 study testing Insulin in people with Angiogenesis, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
Trial summary
Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Angiogenesis
- What is being tested?
- Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2014to May 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nondiabetic patients with full-thickness acute wounds
Who cannot join
- Diabetic patients
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, 78290
About this study
Official title: Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients
Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
Read the detailed description
Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
- Conditions
- Angiogenesis
- Being tested
- Insulin, Placebo
- Keywords
- Blood vessel, Fibroplasia, Wound healing, Insulin
- Medical subject headings
- Fibrosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Half of the wound surface was treated daily with 10 units of intermediate insulin.
PlaceboDrug
Also called Normal saline
Half of the wound surface was treated daily with 0.1 cc of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | Half of the wound surface was treated daily with intermediate insulin. Allocation was randomized. Receives: Drug: Insulin |
| Placebo | Placebo comparator | Half of the wound surface was treated daily with normal saline. Allocation was randomized. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood vessels
In a biopsy taken at baseline, blood vessels will be counted
Measured: 14 days
Secondary outcomes (1)
Hypoglycaemia
Presence of capillary blood glucose of <60 mg/dl
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2015 (estimated)
- Study completionMay 2015 (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 AngiogenesisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Responsible party
- Principal investigator, MARIO AURELIO MARTÍNEZ-JIMÉNEZ, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Jorge Aguilar-García, MD, Study chair, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396888
- Sponsor's protocol ID
- 71-13
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martinez-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 24281606
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients
- ClinicalTrials.gov ID
- NCT02396888
- Acronym / sponsor ID
- 71-13
- Conditions
- Angiogenesis
- Keywords
- Blood vessel, Fibroplasia, Wound healing, Insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- 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.
Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
Detailed description
Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Drug: InsulinHalf of the wound surface was treated daily with intermediate insulin. Allocation was randomized. |
| Placebo | Placebo comparator | Drug: PlaceboHalf of the wound surface was treated daily with normal saline. Allocation was randomized. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nondiabetic patients with full-thickness acute wounds
Key exclusion criteria (1 listed)
- Diabetic patients
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 |
|---|---|---|
| InsulinHalf of the wound surface was treated daily with 10 units of intermediate insulin. | Drug | Insulin |
| PlaceboAlso: Normal salineHalf of the wound surface was treated daily with 0.1 cc of normal saline. | Drug | Placebo |
Primary outcome
Number of blood vessels
Time frame: 14 days
In a biopsy taken at baseline, blood vessels will be counted
1 secondary outcome
Hypoglycaemia
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- 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.
Related trials for Angiogenesis
Not yet recruitingPhase 2
Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer
High-grade Serous Ovarian Cancer
Not yet recruitingPhase 2
First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma
Peritoneal Mesothelioma, First-line Therapy
RecruitingPhase 1/2
CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced / Metastatic Solid Tumors
RecruitingPhase 1/2
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
Kaposi Sarcoma
Active, not recruiting
Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents
Kidney Cancer
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.
Jorge Aguilar-García, MD study chair
Hospital Central "Dr. Ignacio Morones Prieto"
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 in people with Angiogenesis, 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 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 Mar 2015. 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?
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?
Number of blood vessels (time frame: 14 days). 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 NCT02396888, 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 24 Mar 2015.