DIABETIC FOOT ULCERSMDTNCT01681160
Study of Maggot Therapy in Diabetic Foot Ulcers
A study testing procedure:maggot therapy and conventional therapy in people with DIABETIC FOOT ULCERS, run by Kerman Medical University.
Trial summary
This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- DIABETIC FOOT ULCERS
- What is being tested?
- procedure:maggot therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2011
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a chronic illness more than 7 weeks.
- The age of the patients between 40- 90 years old.
- Not having capillary disease (Blockage of artery, Rinold).
- Not user of anticoagulants and corticosteroids drugs.
- Patients without history of allergy to drugs and foods.
- Having diabetic type 2
Who cannot join
- patients who refer to critical clinical care unit
- patients who have amputation
About this study
Official title: Maggot Therapy in Diabetic Foot Ulcers
This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.
- Conditions
- DIABETIC FOOT ULCERS
- Being tested
- procedure:maggot therapy, conventional therapy
- Keywords
- MAGGOT THERAPY, DIABETIC FOOT, NURSING CARE, DRESSING
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedure:maggot therapyOther
Also called larval therapy
each times in maggot therapy continued for three days.wound assessment was done before and after any intervention
conventional therapyOther
Also called mechanical debridement
patients receive ordinary treatment for diabetic foot
| Study group | Role | What they receive |
|---|---|---|
| MAGGOT THERAPY & conventional therapy T | Experimental | Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group Receives: Other: procedure:maggot therapy; Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIABETIC FOOT ULCERSStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerman Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forough Pouryazdanpanah Kermani, Kerman Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681160
- Sponsor's protocol ID
- 86/116
- Acronym
- MDT
- Status last verified
- Sep 2012
- First submitted
- 4 Sep 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maggot Therapy in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01681160
- Acronym / sponsor ID
- MDT / 86/116
- Conditions
- DIABETIC FOOT ULCERS
- Keywords
- MAGGOT THERAPY, DIABETIC FOOT, NURSING CARE, DRESSING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Kerman Medical UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Sep 2012 (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.
This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAGGOT THERAPY & conventional therapy T | Experimental | Other: procedure:maggot therapy, Other: conventional therapyMaggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a chronic illness more than 7 weeks.
- The age of the patients between 40- 90 years old.
- Not having capillary disease (Blockage of artery, Rinold).
- Not user of anticoagulants and corticosteroids drugs.
- Patients without history of allergy to drugs and foods.
Key exclusion criteria (2 listed)
- patients who refer to critical clinical care unit
- patients who have amputation
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 |
|---|---|---|
| procedure:maggot therapyAlso: larval therapyeach times in maggot therapy continued for three days.wound assessment was done before and after any intervention | Other | MAGGOT THERAPY & conventional therapy T |
| conventional therapyAlso: mechanical debridementpatients receive ordinary treatment for diabetic foot | Other | MAGGOT THERAPY & conventional therapy T |
Primary outcome
change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days
Time frame: 2 years
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 10 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing procedure:maggot therapy and conventional therapy in people with DIABETIC FOOT ULCERS, run by Kerman Medical University.
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 2 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days (time frame: 2 years). 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 10 Sep 2012; AzTrials last refreshed its copy on 6 Nov 2026.