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IRCT20170723035248N2 IRCT 2018-03-21 Ghoum University of Medical Sciences Efficacy of maggot therapy on diabetic foot ulcers Comparison of the effectiveness of maggot therapy in removing necrotic tissues and pathogenic bacteria in diabetic foot ulcers in grade of Wagner 2 2018-02-20 anticipated 56 Complete https://irct.ir/trial/26691 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, ِDice drooped and the bloc number will be selected. this procedure continued to completed the allocation and reached to sample size. 3 Diabetic foot ulcer. Intervention 1: Intervention group: In addition to receiving the routine treatment that the control group will receive, the prescription of the larvae of the flies (Lucilia sericata larvae) is also used to treat diabetic foot ulcer. Routine therapy involves local and systemic measures, including blood glucose uptake, debridement, wet dressing, nutritional support, and antibiotic therapy. The number of larvae per wound in order to maggot therapy as process in healing of wounds, varies. It is depending on the extent and depth of the wound and the degree of infection in different parts of the damaged site in the wound. But usually, there are 8 to 10 larvae per cm2 of ulcer. Interventions will be done every 48-72 hours. Interventions in this plan will only be carried out by a licensed medical staff such as a doctor and a nurse. In this plan, the duration of the intervention will be until complete remove of the necrotic tissue. Intervention 2: Control group: They will receive only routine treatment for diabetic foot ulcers. Yes - There is a plan to make this available What will be shared: Demographic data including age and gender When: Starting of sharing one year after case selection. To whom: Data will available for scientists working in academic institutions or people working in businesses can also apply to receive it. Conditions: Using of the shared data will be free for use in academic research. Where to obtain: Deputy of Research and Technology of Ghoum University of Medical Sciences How to obtain: People who need to have data of this study should write formally to Deputy of Research and Technology of Ghoum University of Medical Sciences. Comments:
public Abedin Saghafipour
Faculty of Health, Ghoum University of Medical Sciences, Rohollah Square
Ghoum Iran (Islamic Republic of) 3711675549 +98 25 3784 2228 asaghafi@muq.ac.ir Ghoum University of Medical Sciences scientific Kamran Akbarzadeh
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 14155-6446 +98 21 8895 1393 kakbarzadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients who have at least one diabetic foot ulcer (grade s, Wagners’ classification). Patients who have not osteomeyelies. Patients who have not need to be hospitalized. Patients who have not acute or other chronic diseases. Patients who have not need anticoagulant or steroid pharmaceutics. Patients who have ُnot addicted to alcohol or opium. no limit no limit Both Patients who have sever diseases such as heart disorders and so on during maggot Therapy. Patients who have sever pain during maggot Therapy. Patients who get sever and un-controlled fever during maggot therapy. Patients with maceration around the wound after each interval of maggot therapy. Patients who need emergent hospitalization during or after of each interval of maggot therapy. Patients who take bleeding during maggot therapy. L98.4 Chronic ulcer of skin NOS Treatment - Surgery Treatment - Surgery Intervention group: In addition to receiving the routine treatment that the control group will receive, the prescription of the larvae of the flies (Lucilia sericata larvae) is also used to treat diabetic foot ulcer. Routine therapy involves local and systemic measures, including blood glucose uptake, debridement, wet dressing, nutritional support, and antibiotic therapy. The number of larvae per wound in order to maggot therapy as process in healing of wounds, varies. It is depending on the extent and depth of the wound and the degree of infection in different parts of the damaged site in the wound. But usually, there are 8 to 10 larvae per cm2 of ulcer. Interventions will be done every 48-72 hours. Interventions in this plan will only be carried out by a licensed medical staff such as a doctor and a nurse. In this plan, the duration of the intervention will be until complete remove of the necrotic tissue. Control group: They will receive only routine treatment for diabetic foot ulcers. Measuring surface of necrotic tissue. Timepoint: 48 and 96 hours after treatment. Method of measurement: photographing and measuring by MATLAB 1.6, the mathworks Inc, natic, ma, 2000. Bacterial infections, Staphilococcus aureus and Pseudomonas aeruginosa. Timepoint: 48 and 96 hours after treatment. Method of measurement: culturing of samples in laboratory. Ghoum University of Medical Sciences Approved 2017-07-04 Ethics Committee of Qom University of Medical Sciences Ghoum University of Medical Sciences, Safa Shahr Avenue, Building of Research and Technology Deputy Ghoum Ghoum Iran (Islamic Republic of)