Nutritional, Metabolic, Endocrine Skin and Connective Tissue Diseases
Conditions
Interventions
Sponsors
Dr. Abdulsalam Mohammed Yakasai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Provision of signed and dated informed consent form 2)Male or Female 3)Age:18-90 years old at the time of Informed Consent (Adult, Senior) 4)Type 1 or type 2 Diabetes Mellitus 5)Presence of a diabetic foot ulcer located in the ankle area or below that has persisted a minimum of 3 months prior to the screening visit 6) Ulcer grade classified as =3 according to Wagner grading system or IA according to University of Texas Classification of Diabetic Foot Ulcers. 7) Area of ulcer (after debridement) is at least 4 cm2 8) Arterial perfusion: Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.7 or that have documented confirmation of adequate arterial perfusion 9) For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
Exclusion criteria
Exclusion criteria: 1) Pre-existing conditions - evidence of gangrene on any part of affected limb, active Charcot's foot on the study limb; infection at time of screening, deep vein thrombosis (DVT), active malignancy, being on dialysis, anemia (Hb 12% (uncontrolled hyperglycemia) 10)Pregnant at the time of screening 11) Has any photobiomodulation (low level laser) device at home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| wound closure | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life | — |
Countries
Nigeria
Contacts
Public ContactABDULLAHI MOHAMMED MAHMUD
Head ethics committee
Outcome results
None listed