Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds

NCT ID: NCT06445699

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-08-31

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.

Detailed Description

Randomly divide the enrolled patients into three groups for treatment by utilizing SAS software (SAS Institute, Cary, NC, U.S.A.). Initially, the wound pus and secretions were washed three times with a sterile saline solution. Subsequently, surgical instruments were employed to debride the wound, particularly the necrotic tissue, as well as any carrion and foreign bodies within the wound bed and cavity, with care being taken to avoid injury to nerves and blood vessels in the surrounding area. Grp.1 was covered with hydrogel dressing (PAUL HARTMANN AG, Germany) and replaced 2-3 times a week with topical mupirocin ointment three times a day. Grp.2 received photodynamic therapy only. Grp.3 accepted PDT, then coated with hydrogel dressing as mentioned above. The treatment protocol of PDT is described as follows: after thorough debridement, ALA (Shanghai Fudan-Zhang jiang Bio-Pharmaceutical Co. Ltd, China) in an oil-in-water emulsion was smeared on the wound. After covering with dark plastic film for 3h, the wounds were illuminated by a light-emitting diode (LED) red light (Shenzhen Lifotronic Technology Co., Ltd, China). After the operation, a cold ice compress can be used to relieve the swelling and pain. Then, the hydrogel was uniformly applied to the wound and its surroundings (Grp.3). Grp.2 and Grp.3 received PDT at an interval of ten days for 4 sessions. In all groups, treatment responses and adverse reactions were recorded. All patients received the treatment as mentioned above and then evaluated the clinical outcome. After the end of the treatment, all patients returned for follow up at weeks 2, 4, 8 and 12.

Conditions

Photodynamic Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (Grp.1)

The patients received hydrogel dressing change at three days intervals

Group Type: ACTIVE_COMPARATOR

Hydrogel dressing

Intervention Type: 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 2 (Grp.2)

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

Group Type: EXPERIMENTAL

Photodynamic therapy

Intervention Type: 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 3 (Grp.3)

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

Group Type: EXPERIMENTAL

Photodynamic therapy

Intervention Type: 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.

Hydrogel dressing

Intervention Type: 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.

Interventions

Photodynamic therapy

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.

Intervention Type: OTHER

Hydrogel dressing

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.

Intervention Type: OTHER

Eligibility Criteria

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 wounds or worsening infections;
• 4) Poor compliance leading to an inability to complete the treatment in its entirety;
• 5) Cutaneous ulcer caused by vascular disease, autoimmune diseases, metabolic diseases, local or metastatic malignant tumors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Army Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Rui Yin

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Yin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Yin, MD, PhD

Role: CONTACT

swyinrui@163.com

13101201667

Pan Chen, MS

Role: CONTACT

237429527@qq.com

18502362884

Facility Contacts

Rui Yin, MD, PhD

Role: primary

swyinrui@163.com

13101201667

Pan Chen, MS

Role: backup

237429527@qq.com

18502362884

References

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.

Reference Type: BACKGROUND

PMID: 29289704 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36192814 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32231263 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23066973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35751637 (View on PubMed)

Other Identifiers

RYin

Identifier Type: -

Identifier Source: org_study_id