Skip to content

Efficacy of Biobag in treatment of diabetic foot ulcers

A clinical trial on efficacy of Biobag (disinfected larvae of Lucilia sericata in bag) as new tool in maggot therapy of diabetic foot ulcers

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017053134272N1
Enrollment
52
Registered
2017-09-11
Start date
2017-04-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ulcer of skin NOS. Chronic ulcer of skin, not elsewhere classified

Interventions

Intervention 1: Patients in control group will receive maggot therapy beside of routine treatment process. Intervention 2: Patients in intervention group will receive Biobag as an additional method in
Treatment - Surgery
Patients in control group will receive maggot therapy beside of routine treatment process.
Patients in intervention group will receive Biobag as an additional method in healing process.

Sponsors

Vice Chancellor of Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patient's age between 30 - 80, patients with at least one diabetic foot ulcer, second degree (based on Wagner); having ankle-brachial index (ABI) more than 0.6 or two clear beats on ulcerated leg; not need to be hospitalized; lack of other dangerous diseases; no need for anticoagulant or steroid pharmaceutics; n?ot addicted to alcohol or opium; no entomophobia; to sign the consent. Exclusion criteria: Having sever diseases such as heart disorders and so on, Sever pain during maggot Therapy, Sever and un-controlled fever during maggot therapy, maceration around the wound after each interval of maggot therapy, Emergent hospitalization during or after of each interval of maggot therapy, Bleeding during maggot therapy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Measuring of 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.

Secondary

MeasureTime frame
Measuring of granulated tissue. Timepoint: 48 and 96 hours after treatment. Method of measurement: photgraphing and measuring by MATLAB 1.6, the mathworks Inc, natic, ma, 2000.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Javad Rafinejad

Tehran University of Medical Sciences

jrafinejad@tums.ac.ir+98 21 4293 3121

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026