Diabetic Foot UlcerPhase 1/2NCT02632877
Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
A Phase 1/2 study testing Pirfenidone with MODD and Ketanserin in people with Diabetic Foot Ulcer, run by University of Guadalajara at 2 sites in Mexico.
Trial summary
Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene, diet and life style. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Pirfenidone with MODD and Ketanserin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesMexico
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic for diabetic foot ulcer grade I to II according to Wagner scale
- Volunteer patients that accept to sign an informed consent letter
- Patients that agree to fill a clinical history, access to physical exploration and biochemical analysis samples, ulcer biopsy and photodocumentation of ulcer progress.
- Patients willing to sign a compliance letter to apply treatment as indicated by the principal investigator.
Who cannot join
- Patients with another chronic disease like venous insufficiency or cardiopathy.
- Patients with severe arteriopathy that do not have possibility to direct revascularization like the ones subject to graft tissue, plastics or stents positioning.
- Patients with severe arteriopathy that do not have possibility to indirect vascularization like the ones subject to sympathectomy .
- Elimination criteria:
- Patients without adherence to treatment
- Patients that miss medical appointments
- Patients that show allergy to the 8% 5-methyl-1-phenyl-2-(1h pyridone gel and MODD or any of its components.
- Patients allergic to the 2% ketanserin gel or any of its components.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Molecular Biology and Gene Therapy Institute
Guadalajara, Jalisco, 44340
Hospital Valentín Gómez Farías
Zapopan, Jalisco
About this study
Official title: Efficacy of Pirfenidone Gel Combined With Modified Oxide Diallyl Disulfide (MODD) Versus Ketanserin for the Treatment of Diabetic Foot Ulcers
Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene, diet and life style.
DFU results as a complication in diabetic patients and it is the most common cause of non-traumatic foot amputation in people older than 50 years. Foot amputation decreases patients´ quality of life since only 33% of them will continue walking with the use of a prothesis.
Read more
However, 30% of patients subjected to amputation will die in the first year after surgery and by the 5th year, post-surgery 50% of them will need the amputation of the remaining body extremity.
According to the World Foundation for Diabetes, in Latin America there are 18 million people with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30 million.
Medical expenses for diabetic patients are calculated to be around 8,000 million dollars, annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10 millions of diabetic patients.
Amputation due to DFU complications has many social and economic implications. In Mexico in 2011 diabetes mellitus complications were the principal cause of death in the institute of mexican social security (IMSS) population.
On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an anti-inflammatory drug that promotes re-epithelization due to fibroblast stimulation, angiogenesis and vasculogenesis during tissue remodeling.
According to this, the investigators believe that PFD could play an important role in DFU resolution and for this reason, the investigators consider necessary to analyze the efficacy of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed improvement in chronic skin ulcers in pilot studies.
Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient for and adequate control of diabetic patients.
Then, it is important to develop efficient therapies for the treatment of DFU. In this context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic parameters.
Topical administration of ketanserin has showed beneficial effects in inflammation, granulation and epithelization.
Since these two drugs have showed beneficial effects in tissue regeneration, the investigators believe it is important to compare their safety and efficacy for the treatment of DFU
Read the detailed description
Subjects will be randomized using a random number table to distribute in the control (ketanserin) and the experimental group (PFD+MODD). Demographics data and medical history will be registered on a monthly basis, relative ulcer volume will be calculated by measuring the longest, widest and deepest ulcer side with sterile flexible graduated ruler. The ulcer will be classified according to Wagner scale and photographs will be taken. Ulcer area will be washed with aseptic solution (accua aseptic solution™) and a biopsy of around 10-15 mm3 will be taken from the middle of the ulcer using a scalpel blade. Patients in the experimental group will receive topical PFD+MODD (8% gel) three times a day and patients in control group will receive ketanserin (2% cream) twice a day. Both groups will apply the medicament for six months previous cleansing of the area. Biopsies will be taken at the beginning, at month one and month two. After this time, only photographs will be performed, and relative ulcer volume will be measured. 5 ml of blood will be taken at the beginning and the end of the study to measure general clinical parameters.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Pirfenidone with MODD, Ketanserin
- Keywords
- pirfenidone, Modified oxide diallyl disulfide (MODD), ketanserin, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone with MODDDrug
Also called KitosCell Q, 5-methyl-1-phenyl-2(1H)-pyridone with MODD
Patients with diabetic foot ulcer will be treated three times a day with a smooth layer (standar finger tip unit 0.5g for an area of 100 to 120 square centimeters) of KitosCell Q (Pirfenidone with MODD) in form of gel and the wound will be covered with a bandage.
KetanserinDrug
Also called sufrexal
Patients will be administered ketanserin twice a day usign the standar finger tip unit (0.5g for an area of 100 to 120 square centimeters) and the wound will be covered with a bandage. This arm is a control for evolution of diabetic foot ulcer.
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone with MODD | Experimental | Active ingredients: Pirfenidone 8% with modified oxide diallyl disulfide (MODD) 0.016%.
Dosage form: gel. Dosage: standar finger tip unit (0.5g for an area of 100 to 120 square centimeters).
Frequency and duration: topically applied every eight hours for 6 months. Receives: Drug: Pirfenidone with MODD |
| Ketanserin | Active comparator | Active ingredients: Ketanserin 2%. Dosage form: gel. Dosage: standar finger tip unit (0.5g for an area of 100 to 120 square centimeters).
Frequency and duration: topically applied every 12 hours for 6 months. Receives: Drug: Ketanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing change of ulcerated area
mm3
Measured: 1, 2, 3, 4, 5, and 6 months
Secondary outcomes (9)
mRNA levels of collagen type I alpha (COL-1a)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Transforming growth factor 1-beta (TGFb-1)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Transforming growth factor 3-beta (TGFb-3)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Vascular endothelial growth factor (VEGF)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Tumor necrosis factor alpha (TNFa)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Hypoxia-inducible factor 1-alpha (HIF-1a)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Hypoxia-inducible factor 1-betha (HIF-1b)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Keratinocyte Growth Factor (KGF)
expression relative units
Measured: 0, 1 and 2 months
mRNA levels of Matrix metalloproteinase-1 (MMP-1)
expression relative units
Measured: 0, 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Cell Pharma
- Responsible party
- Principal investigator, Juan Armendáriz-Borunda, University of Guadalajara
- Investigators
- Juan Armendariz-Borunda, PhD, FAASLD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632877
- Sponsor's protocol ID
- IBMMTG.14
- Other IDs
- ISSSTE/CEI/TR/2014/01, Institute of Molecular Biology
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pirfenidone Gel Combined With Modified Oxide Diallyl Disulfide (MODD) Versus Ketanserin for the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02632877
- Acronym / sponsor ID
- IBMMTG.14
- Conditions
- Diabetic Foot Ulcer
- Keywords
- pirfenidone, Modified oxide diallyl disulfide (MODD), ketanserin, diabetic foot ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Cell Pharma
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 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.
Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene, diet and life style.
DFU results as a complication in diabetic patients and it is the most common cause of non-traumatic foot amputation in people older than 50 years. Foot amputation decreases patients´ quality of life since only 33% of them will continue walking with the use of a prothesis.
However, 30% of patients subjected to amputation will die in the first year after surgery and by the 5th year, post-surgery 50% of them will need the amputation of the remaining body extremity.
According to the World Foundation for Diabetes, in Latin America there are 18 million people with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30 million.
Medical expenses for diabetic patients are calculated to be around 8,000 million dollars, annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10 millions of diabetic patients.
Amputation due to DFU complications has many social and economic implications. In Mexico in 2011 diabetes mellitus complications were the principal cause of death in the institute of mexican social security (IMSS) population.
On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an anti-inflammatory drug that promotes re-epithelization due to fibroblast stimulation, angiogenesis and vasculogenesis during tissue remodeling.
According to this, the investigators believe that PFD could play an important role in DFU resolution and for this reason, the investigators consider necessary to analyze the efficacy of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed improvement in chronic skin ulcers in pilot studies.
Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient for and adequate control of diabetic patients.
Then, it is important to develop efficient therapies for the treatment of DFU. In this context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic parameters.
Topical administration of ketanserin has showed beneficial effects in inflammation, granulation and epithelization.
Since these two drugs have showed beneficial effects in tissue regeneration, the investigators believe it is important to compare their safety and efficacy for the treatment of DFU
Detailed description
Subjects will be randomized using a random number table to distribute in the control (ketanserin) and the experimental group (PFD+MODD). Demographics data and medical history will be registered on a monthly basis, relative ulcer volume will be calculated by measuring the longest, widest and deepest ulcer side with sterile flexible graduated ruler. The ulcer will be classified according to Wagner scale and photographs will be taken. Ulcer area will be washed with aseptic solution (accua aseptic solution™) and a biopsy of around 10-15 mm3 will be taken from the middle of the ulcer using a scalpel blade. Patients in the experimental group will receive topical PFD+MODD (8% gel) three times a day and patients in control group will receive ketanserin (2% cream) twice a day. Both groups will apply the medicament for six months previous cleansing of the area. Biopsies will be taken at the beginning, at month one and month two. After this time, only photographs will be performed, and relative ulcer volume will be measured. 5 ml of blood will be taken at the beginning and the end of the study to measure general clinical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone with MODD | Experimental | Drug: Pirfenidone with MODDActive ingredients: Pirfenidone 8% with modified oxide diallyl disulfide (MODD) 0.016%. Dosage form: gel. Dosage: standar finger tip unit (0.5g for an area of 100 to 120 square centimeters). Frequency and duration: topically applied every eight hours for 6 months. |
| Ketanserin | Active comparator | Drug: KetanserinActive ingredients: Ketanserin 2%. Dosage form: gel. Dosage: standar finger tip unit (0.5g for an area of 100 to 120 square centimeters). Frequency and duration: topically applied every 12 hours for 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnostic for diabetic foot ulcer grade I to II according to Wagner scale
- Volunteer patients that accept to sign an informed consent letter
- Patients that agree to fill a clinical history, access to physical exploration and biochemical analysis samples, ulcer biopsy and photodocumentation of ulcer progress.
- Patients willing to sign a compliance letter to apply treatment as indicated by the principal investigator.
Key exclusion criteria (8 listed)
- Patients with another chronic disease like venous insufficiency or cardiopathy.
- Patients with severe arteriopathy that do not have possibility to direct revascularization like the ones subject to graft tissue, plastics or stents positioning.
- Patients with severe arteriopathy that do not have possibility to indirect vascularization like the ones subject to sympathectomy .
- Patients without adherence to treatment
- Patients that miss medical appointments
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 |
|---|---|---|
| Pirfenidone with MODDAlso: KitosCell Q, 5-methyl-1-phenyl-2(1H)-pyridone with MODDPatients with diabetic foot ulcer will be treated three times a day with a smooth layer (standar finger tip unit 0.5g for an area of 100 to 120 square centimeters) of KitosCell Q (Pirfenidone with MODD) in form of gel and the wound will be covered with a bandage. | Drug | Pirfenidone with MODD |
| KetanserinAlso: sufrexalPatients will be administered ketanserin twice a day usign the standar finger tip unit (0.5g for an area of 100 to 120 square centimeters) and the wound will be covered with a bandage. This arm is a control for evolution of diabetic foot ulcer. | Drug | Ketanserin |
Primary outcome
assessing change of ulcerated area
Time frame: 1, 2, 3, 4, 5, and 6 months
mm3
9 secondary outcomes
mRNA levels of collagen type I alpha (COL-1a)
Time frame: 0, 1 and 2 months
mRNA levels of Transforming growth factor 1-beta (TGFb-1)
Time frame: 0, 1 and 2 months
mRNA levels of Transforming growth factor 3-beta (TGFb-3)
Time frame: 0, 1 and 2 months
mRNA levels of Vascular endothelial growth factor (VEGF)
Time frame: 0, 1 and 2 months
mRNA levels of Tumor necrosis factor alpha (TNFa)
Time frame: 0, 1 and 2 months
mRNA levels of Hypoxia-inducible factor 1-alpha (HIF-1a)
Time frame: 0, 1 and 2 months
mRNA levels of Hypoxia-inducible factor 1-betha (HIF-1b)
Time frame: 0, 1 and 2 months
mRNA levels of Keratinocyte Growth Factor (KGF)
Time frame: 0, 1 and 2 months
mRNA levels of Matrix metalloproteinase-1 (MMP-1)
Time frame: 0, 1 and 2 months
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 Dec 2015.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Juan Armendariz-Borunda, PhD, FAASLD study director
University of Guadalajara
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pirfenidone with MODD and Ketanserin in people with Diabetic Foot Ulcer, run by University of Guadalajara at 2 sites 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 4 inclusion and 8 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
assessing change of ulcerated area (time frame: 1, 2, 3, 4, 5, and 6 months). 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 17 Dec 2015.