search
Back to results

Study of Maggot Therapy in Diabetic Foot Ulcers (MDT)

Primary Purpose

DIABETIC FOOT ULCERS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
procedure:maggot therapy
conventional therapy
Sponsored by
Kerman Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DIABETIC FOOT ULCERS focused on measuring MAGGOT THERAPY, DIABETIC FOOT, NURSING CARE, DRESSING

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MAGGOT THERAPY & conventional therapy T

    Arm Description

    Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2012
    Last Updated
    September 7, 2012
    Sponsor
    Kerman Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01681160
    Brief Title
    Study of Maggot Therapy in Diabetic Foot Ulcers
    Acronym
    MDT
    Official Title
    Maggot Therapy in Diabetic Foot Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kerman Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    DIABETIC FOOT ULCERS
    Keywords
    MAGGOT THERAPY, DIABETIC FOOT, NURSING CARE, DRESSING

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MAGGOT THERAPY & conventional therapy T
    Arm Type
    Experimental
    Arm Description
    Maggot therapy,ADMINISTERED TWO TIMES AS A NEW METHODS OF DRESSING in experimental group.conventional therapy ,administered two times in control group
    Intervention Type
    Other
    Intervention Name(s)
    procedure:maggot therapy
    Other Intervention Name(s)
    larval therapy
    Intervention Description
    each times in maggot therapy continued for three days.wound assessment was done before and after any intervention
    Intervention Type
    Other
    Intervention Name(s)
    conventional therapy
    Other Intervention Name(s)
    mechanical debridement
    Intervention Description
    patients receive ordinary treatment for diabetic foot
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Maggot Therapy in Diabetic Foot Ulcers

    We'll reach out to this number within 24 hrs