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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Photodynamic therapy
Other interventionA number of studies have reported that PDT can accelerate wound healing by inactivating local bacterial infection and colonization of bacterial biofilm, promoting wound re-epithelialization.
Hydrogel dressing
Other interventionHydrogel dressing is widely applied in clinical practice to improve the regeneration ability of wound granulation tissue, promote the division and migration of epithelial cells, speed up wound healing and relieve the pain.
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Group 1 (Grp.1)Active comparator 1 intervention
Group B: Group 2 (Grp.2)Experimental treatment 1 intervention
Group C: Group 3 (Grp.3)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Wound healing rate
Panoramic photographs of the wounds were taken by the same observer at each treatment and return visit using a digital camera, and the wound area was recorded using Image-Pro Plus 6.0 software. Wound size on the first day of treatment was considered to be 100%. The change in wound area size was compared to the initial before treatment and calculated as a percentage reduction.
Time frame
Up to 12 weeks after the end of the treatment.2
The total effectiveness rate
The evaluation criteria were as follows: 1) If the wound area is completely healed, treatment was considered "significantly effective" (SE); 2) if the wound area was at least 50% healed, treatment was considered "effective" (E); 3) If the wound area was healed 30 - 50%, the treatment is considered as "improved" (IMP); 4) If the wound area is healed less than 30%, it is considered as "ineffective" (INE). "The total effectiveness rate" (Et) was calculated from the equation as follows: Et = (NSE+NE)/Nt × 100% NSE = the number of patients belonging to the SE groups NE = the number of patients belonging to the E groups Nt = the total number of patients
Time frame
Up to 12 weeks after the end of the treatment.3
Patient satisfaction
Patients were surveyed about their level of satisfaction with the results after 12 weeks following the final course of treatment with the results as "satisfied," "somewhat satisfied," "somewhat dissatisfied," or "dissatisfied."
Time frame
Up to 12 weeks after the end of the treatment.Other outcomes
1
Adverse effects
The severity (absent; mild; moderate; severe) and duration of adverse reactions such as pain, burning sensation, erythema, oedema and pigmentation, treatment measures and efficacy were meticulously documented at each treatment and follow-up.
Time frame
Up to 12 weeks after the end of the treatment.2
Recurrence
Patients were surveyed about the recurrence after 12 weeks following the final course of treatment.
Time frame
Up to 12 weeks after the end of the treatment.Sponsors and contacts
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Source ClinicalTrials.gov