Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds
63 patients with chronic infectious wounds were enrolled in the controlled study. They were randomly divided into three groups equally. Group 1 (Grp.1): The patients received hydrogel dressing change at three days intervals. Group 2 (Grp.2): The patients received ALA-PDT treatment at ten days intervals for 4 sessions.
| Condition(s) | Photodynamic Therapy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 63 patients with chronic infectious wounds were enrolled in the controlled study. They were randomly divided into three groups equally. Group 1 (Grp.1): The patients received hydrogel dressing change at three days intervals. Group 2 (Grp.2): The patients received ALA-PDT treatment at ten days intervals for 4 sessions. Groups 3 (Grp.3): The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals. The wound healing rate, total effective rate, patient satisfaction, adverse reaction, and recurrence were assessed in all groups. |
| Who can participate | Inclusion Criteria: * 1\) patients with chronic wounds caused by trauma or surgery who failed to heal after traditional formal medical treatment at least over three months; * 2\) Patients with stable vital signs who had no systemic medical disease and did not take glucocorticoids, immunosuppressive agents, or anticoagulants during the entire treatment process; * 3\) Participants provided signed informed consent, were able to comply with the program, were willing to participate in follow-up, and were able to cooperate in the observation of adverse events and efficacy; * 4\) The diameter of the skin wound should not exceed 10 centimeters. Exclusion Criteria: * 1\) Patients are allergic to ALA; * 2\) Women with recent fertility, pregnancy or lactation plans; * 3\) Patients with deepening woun |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Army Medical University, China |
| Locations | Chongqing, Chongqing Municipality, China |
| Start date | 2023-01-01 |
| NCT ID | NCT06445699 |
| Official listing | https://clinicaltrials.gov/study/NCT06445699 |