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Efficacy of the blended fibroin/aloe gel extract dressing on healing of diabetic foot ulcer comparing to the commercial product

Efficacy of the blended fibroin/aloe gel extract dressing on healing of diabetic foot ulcer comparing to the commercial product

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190205003
Enrollment
116
Registered
2019-02-05
Start date
2019-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Steriods medication Immunosuppressive medication Wound dressing the blended fibroin/aloe gel extract dressing Diabetic foot ulcer

Interventions

An invented wound dressing which the property of fibroin and aloe vera extract has been combined to enhance healing rate and support the healing process. Wound size reduction and the number of complet
the dressing material is different. Wound characteristic and number of complete wound healing is determined to evaluate the efficacy of wound dressing.
Experimental Device,Active Comparator Device
Fibroin/Aloe gel sheet,Lipidohydrocolloid

Sponsors

Individual
Lead Sponsor
Health Systems Research Institute
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Type 1 or 2 diabetes 2.> 20 years of age 3.A foot ulcer > 4 weeks 4.Wound area of between 25 and 2500 mm2

Exclusion criteria

Exclusion criteria: • Known allergy to silk or aloe • Ulcer on foot extending to tendon&#44; periosteum or bone • Infection of bone • Soft tissue infection requiring systemic antibiotics • Arterial insufficiency considered for revascularisatipon • ABI < 0.7 /toe pressure < 30 mmHg • Gangrene on the affected foot • Eschar which was not removable by debridement • Sinus or deep tract in the wound • Ulceration caused primarily by disease other than diabetes • Patients with any other serious disease • Critical renal disease • Immunosuppressants • Systemic corticosteroid therapy

Design outcomes

Primary

MeasureTime frame
Number of Complete wound healing 12 weeks Observe

Secondary

MeasureTime frame
Wound size reduction 12 weeks Photography

Contacts

Public ContactSaran Worasakwutiphong

Faculty of Medicine&#44; Naresuan university

saranw@nu.ac.th0836549491

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026