Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds

NCT06445699 | Recruiting

• 1 other identifier: RYin
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Photodynamic Therapy

Keywords

Wound healing; Aminolaevulinic acid; Photodynamic therapy; Hydrogel dressing

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 12 weeks after the end of the treatment.

• 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

  Up to 12 weeks after the end of the treatment.

• 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."

  Up to 12 weeks after the end of the treatment.

Other Outcomes (2)

• Adverse effects

  Up to 12 weeks after the end of the treatment.

• Recurrence

  Up to 12 weeks after the end of the treatment.

Study Arms (3)

Group 1 (Grp.1)

ACTIVE COMPARATOR

The patients received hydrogel dressing change at three days intervals

Other: Hydrogel dressing

Group 2 (Grp.2)

EXPERIMENTAL

The patients received ALA-PDT treatment at ten days intervals for 4 sessions.

Other: Photodynamic therapy

Group 3 (Grp.3)

EXPERIMENTAL

The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals.

Other: Photodynamic therapy; Other: Hydrogel dressing

Interventions

Photodynamic therapy OTHER

A 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.

Group 2 (Grp.2); Group 3 (Grp.3)

Hydrogel dressing OTHER

Hydrogel 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.

Group 1 (Grp.1); Group 3 (Grp.3)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) patients with chronic wounds caused by trauma or surgery who failed to heal after traditional formal medical treatment at least over three months;
• \) 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;
• \) 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;
• \) The diameter of the skin wound should not exceed 10 centimeters.

You may not qualify if:

• \) Patients are allergic to ALA;
• \) Women with recent fertility, pregnancy or lactation plans;
• \) Patients with deepening wounds or worsening infections;
• \) Poor compliance leading to an inability to complete the treatment in its entirety;
• \) Cutaneous ulcer caused by vascular disease, autoimmune diseases, metabolic diseases, local or metastatic malignant tumors.

Sponsors & Collaborators

• Army Medical University, China: lead

Study Sites (1)

Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Related Publications (5)

• Nesi-Reis V, Lera-Nonose DSSL, Oyama J, Silva-Lalucci MPP, Demarchi IG, Aristides SMA, Teixeira JJV, Silveira TGV, Lonardoni MVC. Contribution of photodynamic therapy in wound healing: A systematic review. Photodiagnosis Photodyn Ther. 2018 Mar;21:294-305. doi: 10.1016/j.pdpdt.2017.12.015. Epub 2017 Dec 28.

  PMID: 29289704 BACKGROUND

• Khorsandi K, Hosseinzadeh R, Esfahani H, Zandsalimi K, Shahidi FK, Abrahamse H. Accelerating skin regeneration and wound healing by controlled ROS from photodynamic treatment. Inflamm Regen. 2022 Oct 4;42(1):40. doi: 10.1186/s41232-022-00226-6.

  PMID: 36192814 BACKGROUND

• Sies H, Jones DP. Reactive oxygen species (ROS) as pleiotropic physiological signalling agents. Nat Rev Mol Cell Biol. 2020 Jul;21(7):363-383. doi: 10.1038/s41580-020-0230-3. Epub 2020 Mar 30.

  PMID: 32231263 BACKGROUND

• Morley S, Griffiths J, Philips G, Moseley H, O'Grady C, Mellish K, Lankester CL, Faris B, Young RJ, Brown SB, Rhodes LE. Phase IIa randomized, placebo-controlled study of antimicrobial photodynamic therapy in bacterially colonized, chronic leg ulcers and diabetic foot ulcers: a new approach to antimicrobial therapy. Br J Dermatol. 2013 Mar;168(3):617-24. doi: 10.1111/bjd.12098. Epub 2013 Jan 18.

  PMID: 23066973 BACKGROUND

• Xu Y, Chen H, Fang Y, Wu J. Hydrogel Combined with Phototherapy in Wound Healing. Adv Healthc Mater. 2022 Aug;11(16):e2200494. doi: 10.1002/adhm.202200494. Epub 2022 Jul 6.

  PMID: 35751637 BACKGROUND

MeSH Terms

Interventions

Photochemotherapy; Bandages, Hydrocolloid

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Bandages; Equipment and Supplies

Study Officials

• Rui Yin, MD, PhD

  Southwest Hospital, Third Military Medical University, Chongqing, 400038, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Yin, MD, PhD

CONTACT

13101201667; swyinrui@163.com

Pan Chen, MS

CONTACT

18502362884; 237429527@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 6, 2024
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)