Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds
ConditionPhotodynamic Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorArmy Medical University, China
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
1) Patients are allergic to ALA;
2) Women with recent fertility, pregnancy or lactation plans;
3) Patients with deepening wounds or worsening infections;
4) Poor compliance leading to an inability to complete the treatment in its entirety;
Trial design
Treatments tested in this trial
- Photodynamic therapy
- Hydrogel dressing
Treatment groups
69 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov