Diabetic foot ulcer Type 2 diabetes mellitus Chronic wound Wound healing Diabetic Foot Diabetes Mellitus, Type 2 Wound Healing Aloe Vera Silver Sulfadiazine Randomized Controlled Trial
Conditions
Interventions
Participants in this group will receive topical Aloe vera gel in addition to silver sulfadiazine cream for the treatment of diabetic foot ulcers. The Aloe vera gel used contains 87.399 percent Aloe ve
Experimental Drug,Active Comparator Drug
Aloe vera gel plus Silver Sulfadiazine cream,Silver Sulfadiazine cream alone
Sponsors
Faculty of medicine King Mongkut Institute of Technology Ladkrabang
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with diabetes mellitus 2. Presence of only one diabetic foot ulcer 3. Ulcer classified as Wagner classification grade 1 to grade 2 4.Ulcer length not more than 5 centimeters 5.BWAT assessment indicating no exudate and no necrotic tissue 6. Adequate peripheral circulation as evidenced by an Ankle Brachial Index ranging from 0.8 to 1.4, or documented evidence of successful vascular revascularization treatment 7. Able to comply with wound care instructions and follow-up procedures throughout the study period 8. Participants with visual impairment or difficulty performing self-care must have a caregiver who is able to assist with wound care and follow study instructions throughout the study period
Exclusion criteria
Exclusion criteria: 1.History of addiction or abuse of cigarettes or alcohol. 2.Receiving medications that may interfere with wound healing, such as: glucocorticoids, immunosuppressive agents, or cytotoxic drugs. 3. Presence of other chronic diseases, including: cancer, congestive heart failure, end-stage renal disease, or liver failure. 4.Diagnosed with Diabetic Ketoacidosis (DKA) or Hyperosmolar Hyperglycemic State (HHS). 5.Known allergy to silver sulfadiazine or aloe vera gel. 6. sulfa allergy 7.Inability to follow instructions. 8.Presence of foot gangrene requiring amputation or osteomyelitis requiring antibiotic therapy during the study. 9.Preference to receive treatment outside the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bates-Jensen Wound Assessment Tool score Baseline and weekly for 4 weeks Bates-Jensen Wound Assessment Tool (BWAT) total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcer size Baseline and week 4 Ulcer surface area measured by digital photography and image analysis ,Visual analogue scale Baseline and week 4 Visual Analogue Scale (VAS) for pain intensity (0 to 10 scale) | — |
Countries
Thailand
Contacts
Public ContactThana Chuenwatthana
King Mongkut's Institute of Technology Ladkrabang
Outcome results
None listed