NCT01681160

Brief 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 professional specially for nurses.One of this new treatment is maggot therapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

September 4, 2012

Last Update Submit

September 7, 2012

Conditions

Keywords

MAGGOT THERAPYDIABETIC FOOTNURSING CAREDRESSING

Outcome Measures

Primary Outcomes (1)

  • change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days

    2 years

Study Arms (1)

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

Other: procedure:maggot therapyOther: conventional therapy

Interventions

each times in maggot therapy continued for three days.wound assessment was done before and after any intervention

Also known as: larval therapy
MAGGOT THERAPY & conventional therapy T

patients receive ordinary treatment for diabetic foot

Also known as: mechanical debridement
MAGGOT THERAPY & conventional therapy T

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients who refer to critical clinical care unit
  • patients who have amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Interventions

Maggot Debridement Therapy

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
university instructor

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2011

Last Updated

September 10, 2012

Record last verified: 2012-09