diabetic foot
Conditions
Interventions
1:Ointment for intervention
2:Placebo ointment
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) aged >=18 years, meeting the diagnostic criteria of diabetic foot ulcer; (2) diagnosed with diabetes (3) Wagner grade 1; Wounds and ulcers are partially penetrated through the epidermis and dermis.The wound may extend to the dermis and subcutaneous tissue, but not to muscles, tendons, bones and joint capsules. (4) no necrotic tissue or infection was found in the wound. (5) the ankle brachial index (ABI) of patients with doppler examination was 0.7. (6) participants should have normal blood circulation around the wound. (7) record blood glucose every day, with acceptable blood glucose control, HbA1c less than 7.5%. (8) obtain the consent of the subject, family, guardian or legal agent and sign the informed consent.
Exclusion criteria
Exclusion criteria: The following criteria shall be excluded if they meet any of the following criteria: (1) clinical evidence of gangrene in any part of the patient's foot. (2) the patient's ulcer was caused by a non-diabetic cause.Arterial ulcers, venous stasis, stress, radiation, traumatic, rheumatoid, vasculitis, collagenous vascular disease, or other non-diabetic causes are not registered. (3) the patient's ulcer has a sinus tract that cannot be completely debridement. (4) uncontrolled diabetes may affect the completion of the study. (5) the patient has one or more diseases, including kidney, liver, hematology, nervous or immune system diseases, which are considered by the researchers to make the patient unsuitable for wound healing research. (6) the patient has or has had malignant disease that has not been alleviated for five years or more (except skin epithelioma). (7) the patient is receiving oral or non-oral corticosteroids, immunosuppressants, or cytotoxic drugs, or is expected to need such drugs during the study. (8) patients with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV). (9) the patient participated in another study using an experimental drug or device within the past 30 days. (10) ulcer infection or associated with active cellulitis and osteomyelitis was determined by the researchers. (11) the patient has any condition that seriously impairs the patient's ability to complete this study. (12) hospitalized patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of skin lesion area;Wound healing rate;Wound healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| pain score;ABI; | — |
Countries
China
Contacts
Public ContactTing Zhao
Affiliated Hospital of Qingdao University
Outcome results
None listed