Photodynamic TherapyNCT06445699
Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds
A study testing Photodynamic therapy and Hydrogel dressing in people with Photodynamic Therapy, run by Army Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Photodynamic Therapy
- What is being tested?
- Photodynamic therapy and Hydrogel dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
Chongqing, Chongqing Municipality, 400038
Rui Yin, MD, PhD, 13101201667, swyinrui@163.com
Pan Chen, MS, 18502362884, 237429527@qq.com
About this study
Official title: Investigation the Clinical Effectiveness of Combination Topical Aminolaevulinic Acid-Photodynamic Therapy With Hydrogel Dressing for Treatment Chronic Cutaneous 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. 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.
Read the 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
- Being tested
- Photodynamic therapy, Hydrogel dressing
- Keywords
- Wound healing, Aminolaevulinic acid, Photodynamic therapy, Hydrogel dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyOther
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 dressingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Grp.1) | Active comparator | The patients received hydrogel dressing change at three days intervals Receives: Other: Hydrogel dressing |
| Group 2 (Grp.2) | Experimental | The patients received ALA-PDT treatment at ten days intervals for 4 sessions. Receives: 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. Receives: Other: Photodynamic therapy; Other: Hydrogel dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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."
Measured: Up to 12 weeks after the end of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jan 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Photodynamic TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Yin, Army Medical University, China
- Investigators
- Rui Yin, MD, PhD, Principal investigator, Southwest Hospital, Third Military Medical University, Chongqing, 400038, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445699
- Sponsor's protocol ID
- RYin
- Status last verified
- Jul 2024
- First submitted
- 21 May 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29289704Khorsandi 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.
PubMed 36192814Sies 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.
PubMed 32231263Morley 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.
PubMed 23066973Xu 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.
PubMed 35751637
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation the Clinical Effectiveness of Combination Topical Aminolaevulinic Acid-Photodynamic Therapy With Hydrogel Dressing for Treatment Chronic Cutaneous Wounds
- ClinicalTrials.gov ID
- NCT06445699
- Acronym / sponsor ID
- RYin
- Conditions
- Photodynamic Therapy
- Keywords
- Wound healing, Aminolaevulinic acid, Photodynamic therapy, Hydrogel dressing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Army Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Grp.1) | Active comparator | Other: Hydrogel dressingThe patients received hydrogel dressing change at three days intervals |
| Group 2 (Grp.2) | Experimental | Other: Photodynamic therapyThe patients received ALA-PDT treatment at ten days intervals for 4 sessions. |
| Group 3 (Grp.3) | Experimental | Other: Photodynamic therapy, Other: Hydrogel dressingThe patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapyA 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. | Other | Group 2 (Grp.2), Group 3 (Grp.3) |
| Hydrogel dressingHydrogel 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. | Other | Group 1 (Grp.1), Group 3 (Grp.3) |
Primary outcome
Wound healing rate
Time frame: Up to 12 weeks after the end of the treatment.
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.
The total effectiveness rate
Time frame: Up to 12 weeks after the end of the treatment.
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
Patient satisfaction
Time frame: Up to 12 weeks after the end of the treatment.
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."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 29289704Nesi-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.
- Background: PubMed 36192814Khorsandi 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.
- Background: PubMed 32231263Sies 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.
- Background: PubMed 23066973Morley 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.
- Background: PubMed 35751637Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Yin, MD, PhD principal investigator
Southwest Hospital, Third Military Medical University, Chongqing, 400038, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic therapy and Hydrogel dressing in people with Photodynamic Therapy, run by Army Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Yin, MD, PhD (13101201667, swyinrui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing rate (time frame: Up to 12 weeks after the end of the treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445699, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.