Diabetic Foot UlcersPhase 2PL-5NCT06189638
Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers
A Phase 2 study of Diabetic Foot Ulcers, run by Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. at 3 sites in United States.
Trial summary
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2024to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 65 years.
- Non-hospitalized ambulatory subjects with Diabetes mellitus, Type I or II, according to the American Diabetes Association criteria.
- HbA1c ≤12% at screening.
- At baseline visit (after any required debridement), presence of Grade 2 diabetic foot infection [Grade 2 of the International Working Group on the Diabetic Foot (IWGDF) classification]
- Infection present, as defined by the presence of at least 2 of the following items:
- Local swelling or induration
Show all 17Show fewer
- Erythema >0.5 cm to ≤2 cm around the ulcer.
- Local tenderness or pain
- Local increased warmth
- Purulent discharge (thick, opaque to white, or sanguineous secretion)
- Mild infection of an ulcer is defined as:
- Presence of ≥2 manifestations of inflammation (purulence or erythema, tenderness, warmth, or induration), but any cellulitis/erythema extends ≤2cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness.
- Voluntary written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
- Female subjects must meet at least one of the following additional criteria:
- Surgically sterile with bilateral tubal ligation or hysterectomy.
- Postmenopausal for at least one year.
- If of childbearing potential, practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence
Who cannot join
- Another cause of the inflammatory response of the skin around the ulcer (such as a trauma, gout, acute Charcot neuro-arthropathy, fracture, thrombosis, or venous stasis).
- Foot deformities, calluses, corns, ingrown nails, fungal infections, which will impact infection or wound healing based on Investigator's judgement.
- Received any topical or systemic antimicrobial therapy within 7 days prior to study entry (Day 1).
- Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
- > 1 infected foot ulcer.
- Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
Show all 10Show fewer
- Bone or joint involvement is suspected based on clinical examination or plain X-ray.
- Arterial brachial index (ABI) <0.5 or ankle pressure <50 mmHg. If ABI is >1.3 (medial calcification is present), then only subjects meeting secondary testing requirements including either a toe pressure ≥30 mmHg, a transcutaneous pressure of oxygen ≥50 mmHg, or a skin perfusion pressure ≥40 mmHg are allowed. For subjects with ABI >1.3, only the initial secondary test after ABI should be used for this assessment. A documented ABI within 3 months prior to Screening is acceptable, as is the initially performed secondary testing method for subjects with ABI >1.3.
- The subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period or cannot safely monitor the infection status at home.
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bioresearch Partner Holdings, LLLP
Miami, Florida, 33175
Santos Research Center, Corp
Tampa, Florida, 33615
ILD Research Center
Vista, California, 92081
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild Infections of Diabetic Foot Ulcers
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and topical placebo (vehicle) spray. In this study, the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study
Read the detailed description
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Approximately 90 patients (30 per treatment group) will be randomized in this study. Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle). In this study, the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study. The duration of the whole study is planned for 24 months; the duration of each participant is about 4-5 weeks, including Screening period/Baseline (about 7 days), treatment period (about 14 days), Follow-up period (about 7-14 days). No interim analysis will be performed in this study. This study is a phase II study, and no statistical hypothesis is proposed.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Antimicrobial Peptide PL-5 Topical Spray and Placebo
- Keywords
- Diabetic Foot Infection, Diabetic Foot, Diabetic, Wound Infection
- Medical subject headings
- Diabetic Foot, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Peptide PL-5 Topical Spray and PlaceboDrug
Also called AMP PL-5 and Placebo
Antimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage.
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial Peptide PL-5 Topical Spray: 1 mg/g (1‰) | Experimental | Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰) Receives: Drug: Antimicrobial Peptide PL-5 Topical Spray and Placebo |
| Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰) | Experimental | Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (2‰) Receives: Drug: Antimicrobial Peptide PL-5 Topical Spray and Placebo |
| Topical placebo (vehicle) | Placebo comparator | Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle). Receives: Drug: Antimicrobial Peptide PL-5 Topical Spray and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
the Investigator will grade the clinical response as （1）"infection resolved or cured" (all signs and symptoms of infection resolved);（2）"infection improving"(most, but not all, signs and symptoms of infection improved or resolved)（3）"treatment failure" (≥1 signs or symptoms of infection substantially worsening), (4)"unevaluable"(<3 days of study treatment or patient lost to follow-up), or （5）"recurrence"(a previously cured or improved infection showing worsening of signs or symptoms of infection)
Measured: At EOT (End-of-therapy: within 24 hours after the final dose)
Secondary outcomes (5)
Microbiological response
Microbiological culture examination of wound tissue; Analysis of drug sensitivity test results; Analysis of MIC50, MIC90, geometric mean inhibitory concentration and range results of clinically isolated pathogenic bacteria. At baseline, day 1, and at all other study visits, Investigators will culture samples obtained from the wound at which culturable material and signs of infection are present. They will obtain specimens using tissue curettage with a sterile scalpel, place them into transport media, and ship them to the designated central laboratory for species identification and antibiotic susceptibility testing. For specific operations of bacteriological examination of wound tissue, please refer to the clinical microbiology operation manual. Result: 1）Resolved;2） Improved;3)Failure 4） Colonization 5） Superinfection.
Measured: Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose.
Comprehensive Response
At EOT and PTE, the Investigator will grade the comprehensive response as （1）"cure"(patients are clinically cured, and the bacteria are eradicated or presumed eradicated.);（2）"failure" (patients are classified as clinical failure or/and microbiological responses are failure and superinfection) or （3）"indeterminate"(if both clinical and microbiological responses are indeterminate).
Measured: End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE):7-14 days after the final dose.
Safety and tolerability
The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), and clinically significant changes in physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG)
Measured: Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose
Clinical response
At each visit after enrollment, the Investigator will grade the clinical response as （1）"infection resolved or cured" (all signs and symptoms of infection resolved);（2）"infection improving"(most, but not all, signs and symptoms of infection improved or resolved)（3）"treatment failure" (≥1 signs or symptoms of infection substantially worsening), (4)"unevaluable"(<3 days of study treatment or patient lost to follow-up), or （5）"recurrence"(a previously cured or improved infection showing worsening of signs or symptoms of infection)
Measured: Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose.
Wound infection Score and Total Wound Score
A "wound infection score" was semiquantitatively assessed by grading each of 7 parameters with a score of 0-3: (1) purulent drainage, (2) nonpurulent drainage, (3) erythema, (4) induration, (5) tenderness, (6) pain, and (7) local warmth.
Measured: At baseline, day 1, and at all other study visits, investigators will compile a "total wound score" that included ratings of signs and symptoms of infection, wound measurements (maximum length, width, and depth), and assessment of granulation tissue.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start30 Jan 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189638
- Sponsor's protocol ID
- 280800-JSPL-PL-5-203
- Acronym
- PL-5
- Status last verified
- May 2025
- First submitted
- 6 Dec 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei Y, Li Y, Li X, Zhao Y, Xu J, Wang H, Rong X, Xiong J, Chen X, Luo G, Lv G, Lin C, Han C, Yu H, Zhang Y, Tang S, Fan Y, Tu J, Xia C, Zu H, Liu W, Liu C, Liu J, Zhang B, Nong Q, Li T, Wang L, Song G, Su Y, Chen Z, Lai W, Fu Y, Yu J, Zhang P, Yang W, Yao G, Zhang H, Fan K, Dong H, Chen Y, Wu J; PL-5 Investigators. Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415310. doi: 10.1001/jamanetworkopen.2024.15310.
PubMed 38861260Wei Y, Wu J, Chen Y, Fan K, Yu X, Li X, Zhao Y, Li Y, Lv G, Song G, Rong X, Lin C, Wang H, Chen X, Zhang P, Han C, Zu H, Liu W, Zhang Y, Liu C, Su Y, Zhang B, Sun B, Wang L, Lai W, Liu J, Xia C, Ji G, Zhu F, Yu J, Ahemaiti A, Dong H, Chen M; PL-5 Investigators. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. Ann Surg. 2023 Jan 1;277(1):43-49. doi: 10.1097/SLA.0000000000005508. Epub 2022 Jul 4.
PubMed 35781462
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild Infections of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06189638
- Acronym / sponsor ID
- PL-5 / 280800-JSPL-PL-5-203
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetic Foot Infection, Diabetic Foot, Diabetic, Wound Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 3 Jan 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.
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and topical placebo (vehicle) spray. In this study, the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study
Detailed description
This is a Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the clinical efficacy and safety of Antimicrobial Peptide PL-5 Topical Spray in patients with mild infections of diabetic foot ulcers. Approximately 90 patients (30 per treatment group) will be randomized in this study. Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle). In this study, the cut-off date for final analysis is defined as the time when all subjects have completed the last visit or discontinued the study. The duration of the whole study is planned for 24 months; the duration of each participant is about 4-5 weeks, including Screening period/Baseline (about 7 days), treatment period (about 14 days), Follow-up period (about 7-14 days). No interim analysis will be performed in this study. This study is a phase II study, and no statistical hypothesis is proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰), Antimicrobial Peptide PL-5 Topical Spray (2‰) and placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle).
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Peptide PL-5 Topical Spray: 1 mg/g (1‰) | Experimental | Drug: Antimicrobial Peptide PL-5 Topical Spray and PlaceboEligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (1‰) |
| Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰) | Experimental | Drug: Antimicrobial Peptide PL-5 Topical Spray and PlaceboEligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Peptide PL-5 Topical Spray (2‰) |
| Topical placebo (vehicle) | Placebo comparator | Drug: Antimicrobial Peptide PL-5 Topical Spray and PlaceboEligible subjects will be randomized (1:1:1) to receive twice a day, 14 days treatment of Antimicrobial Placebo of Antimicrobial Peptide PL-5 Topical Spray (vehicle). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age between 18 to 65 years.
- Non-hospitalized ambulatory subjects with Diabetes mellitus, Type I or II, according to the American Diabetes Association criteria.
- HbA1c ≤12% at screening.
- At baseline visit (after any required debridement), presence of Grade 2 diabetic foot infection [Grade 2 of the International Working Group on the Diabetic Foot (IWGDF) classification]
- Presence of ≥2 manifestations of inflammation (purulence or erythema, tenderness, warmth, or induration), but any cellulitis/erythema extends ≤2cm around the ulcer, and infection is limited to the skin or superficial subcutaneous tissues; no other local complications or systemic illness.
Key exclusion criteria (10 listed)
- Another cause of the inflammatory response of the skin around the ulcer (such as a trauma, gout, acute Charcot neuro-arthropathy, fracture, thrombosis, or venous stasis).
- Foot deformities, calluses, corns, ingrown nails, fungal infections, which will impact infection or wound healing based on Investigator's judgement.
- Received any topical or systemic antimicrobial therapy within 7 days prior to study entry (Day 1).
- Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
- > 1 infected foot ulcer.
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 |
|---|---|---|
| Antimicrobial Peptide PL-5 Topical Spray and PlaceboAlso: AMP PL-5 and PlaceboAntimicrobial Peptide PL-5 Topical Spray At about 5 cm vertically above the wound, the investigator sprays antimicrobial peptide PL-5 topical spray on the test wound. The cover area after spraying is a cone with a surface diameter of about 5 cm and area about 20 cm2. One spray dose is about 0.1 ml. The number of drug sprays is determined according to the wound area in the screening period, and the determined dose is applied consistently. During the operation, an effective spray operation is completely ejected with no leakage. | Drug | Antimicrobial Peptide PL-5 Topical Spray: 1 mg/g (1‰), Antimicrobial Peptide PL-5 Topical Spray:2 mg/g (2‰), Topical placebo (vehicle) |
Primary outcome
Clinical response
Time frame: At EOT (End-of-therapy: within 24 hours after the final dose)
the Investigator will grade the clinical response as （1）"infection resolved or cured" (all signs and symptoms of infection resolved);（2）"infection improving"(most, but not all, signs and symptoms of infection improved or resolved)（3）"treatment failure" (≥1 signs or symptoms of infection substantially worsening), (4)"unevaluable"(<3 days of study treatment or patient lost to follow-up), or （5）"recurrence"(a previously cured or improved infection showing worsening of signs or symptoms of infection)
5 secondary outcomes
Microbiological response
Time frame: Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose.
Comprehensive Response
Time frame: End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE):7-14 days after the final dose.
Safety and tolerability
Time frame: Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose
Clinical response
Time frame: Interim Clinical Evaluation (ICE): 7 days after the initiation of the study drug. End of Therapy (EOT): within 24 hours after the final dose. Post-therapy evaluation (PTE): 7-14 days after the final dose.
Wound infection Score and Total Wound Score
Time frame: At baseline, day 1, and at all other study visits, investigators will compile a "total wound score" that included ratings of signs and symptoms of infection, wound measurements (maximum length, width, and depth), and assessment of granulation tissue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 38861260Wei Y, Li Y, Li X, Zhao Y, Xu J, Wang H, Rong X, Xiong J, Chen X, Luo G, Lv G, Lin C, Han C, Yu H, Zhang Y, Tang S, Fan Y, Tu J, Xia C, Zu H, Liu W, Liu C, Liu J, Zhang B, Nong Q, Li T, Wang L, Song G, Su Y, Chen Z, Lai W, Fu Y, Yu J, Zhang P, Yang W, Yao G, Zhang H, Fan K, Dong H, Chen Y, Wu J; PL-5 Investigators. Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415310. doi: 10.1001/jamanetworkopen.2024.15310.
- Background: PubMed 35781462Wei Y, Wu J, Chen Y, Fan K, Yu X, Li X, Zhao Y, Li Y, Lv G, Song G, Rong X, Lin C, Wang H, Chen X, Zhang P, Han C, Zu H, Liu W, Zhang Y, Liu C, Su Y, Zhang B, Sun B, Wang L, Lai W, Liu J, Xia C, Ji G, Zhu F, Yu J, Ahemaiti A, Dong H, Chen M; PL-5 Investigators. Efficacy and Safety of PL-5 (Peceleganan) Spray for Wound Infections: A Phase IIb Randomized Clinical Trial. Ann Surg. 2023 Jan 1;277(1):43-49. doi: 10.1097/SLA.0000000000005508. Epub 2022 Jul 4.
- As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health.Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Diabetic Foot Ulcers, run by Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. at 3 sites in United States.
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 17 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: At EOT (End-of-therapy: within 24 hours after the final dose)). 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 NCT06189638, which also lists 2 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 25 May 2025.