Trials / Unknown
UnknownNCT05850611
The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer
The Effect of Combination Therapy of Oral Methylene Blue and Platelet-rich Plasma-fibrin Glue in Patients With Non-healing Diabetic Foot Ulcer: a Pilot Study
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Mashhad University of Medical Sciences · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.
Detailed description
The current study assesses the effects of methylene blue along with the use of platelet-rich plasma-fibrin glue on wound healing in patients with nonhealing diabetic foot ulcers (non-healing DFU). This randomized controlled trial is performed on 20 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus 200 ml of oral methylene blue dissolved in milk(intervention group) or PRP-FG dressing plus placebo (200 ml of milk) (control group) for 4 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylene Blue | The first intervention group includes diabetic patients with chronic foot ulcers who, despite common treatments, will be undergone oral methylene blue intervention for 4 weeks. |
| OTHER | Milk (control) | Group B will receive 200 ml of milk for 4 weeks. |
| DRUG | Methylene Blue and Platelet-Rich Plasma-Fibrin Glue | Group C will be undergone synergistic 4-week treatment with oral methylene blue and fibrin glue. |
| OTHER | Milk and Platelet-Rich Plasma-Fibrin Glue (control) | Group D will be treated only with fibrin glue and 200 ml of milk for 4 weeks. |
Timeline
- Start date
- 2023-04-30
- Primary completion
- 2023-08-21
- Completion
- 2024-09-21
- First posted
- 2023-05-09
- Last updated
- 2023-10-04
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT05850611. Inclusion in this directory is not an endorsement.