Diabetes foot
Conditions
Interventions
Group 1:Standard debridement combined with local anti-infective drugs
Group 2:Standard debridement combined with placebo
Sponsors
Sir Run Run Hospital, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 65 years (including 65 years), no gender limited. 2. Non-hospitalized ambulatory subjects with Diabetes mellitus, Type I or II, according to the American Diabetes Association criteria. 3. HbA1c 0.5 cm to =2 manifestations of inflammation (purulence or erythema, tenderness, warmth, or induration), but any cellulitis/erythema extends <=2cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness. 5. Male or female subjects of childbearing age agreed to take effective and safe contraceptive measures during the treatment period and within one week after the treatment (definition of female of childbearing age: women who have not undergone sterilization surgery from menarche to menopause and are able to conceive anatomically and physiologically. Menopause is defined as permanent menopause. If a woman [usually over 45 years old] has natural [spontaneous] menopause for 12 consecutive months, it is considered menopause). 6. Agree to comply with the prohibition and restriction requirements specified in the plan, understand and sign the ICF.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria are met: 1. Foot deformities, calluses, ingrown nails or fungal infections that seriously affect the clinical efficacy evaluation of wound repair. 2. Subjects who have been treated with systemic antibacterial drugs within 72 hours before enrollment, and the drug action time is >= 24 hours, or subjects who have been treated with topical antibacterial drugs for the test wound. If the infection characterization is not improved according to the judgment of the investigator, it can still be included. 3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware. 4. > 1 infected foot ulcer. 5. Concurrent or expected to require systemic antibiotic during the study period for any infection. 6. Bone or joint involvement is suspected based on clinical examination or plain X-ray. 7. Clinically significant peripheral arterial disease requiring vascular intervention. 8. The subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period or cannot safely monitor the infection status at home. 9. During screening, fever (for example, core temperature [tympanic membrane, rectum, esophagus] >=38 degree, oral temperature >=37.5 degree or axillary temperature >=37 degree), or other investigator judged that there were signs of systemic infection. 10. Subjects suffering from rheumatic immune diseases or immune function defects, such as congenital immunodeficiency, those receiving immunosuppressive treatment or those who are HIV positive. 11. Any situation judged by investigator that may increase the risk of the subject or affect the efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological examination of wound surface;Wound area;Wound depth;Wound photography;skin temperature on the wound surface and around the wound;VAS;Infection assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;Procalcitonin;routine urine test;Blood biochemistry;HIV antibody;Blood pregnancy test; | — |
Countries
China
Contacts
Public ContactLiu Yu
Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed