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Study of Maggot Therapy in Diabetic Foot Ulcers (MDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01681160
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
DIABETIC FOOT ULCERS Other: procedure:maggot therapy Other: conventional therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maggot Therapy in Diabetic Foot Ulcers
Study Start Date : January 2009
Primary Completion Date : December 2009
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MAGGOT THERAPY & conventional therapy T
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 therapy
each times in maggot therapy continued for three days.wound assessment was done before and after any intervention
Other Name: larval therapy
Other: conventional therapy
patients receive ordinary treatment for diabetic foot
Other Name: mechanical debridement


Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Responsible Party: Forough Pouryazdanpanah Kermani, university instructor, Kerman Medical University
ClinicalTrials.gov Identifier: NCT01681160     History of Changes
Other Study ID Numbers: 86/116
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by Forough Pouryazdanpanah Kermani, Kerman Medical University:
MAGGOT THERAPY
DIABETIC FOOT
NURSING CARE
DRESSING

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases