Diabetic Foot UlcerPhase 4NCT05368142
Nocardia Cell Wall Skeleton for the Treatment of Diabetic Foot Ulcer Wounds
A Phase 4 study testing Nocardia rubra Cell Wall Skeleton and Silver ions dressing in people with Diabetic Foot Ulcer and Therapy, Directly Observed, run by The Affiliated Hospital of Xuzhou Medical University.
Trial summary
This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer, Therapy, Directly Observed
- What is being tested?
- Nocardia rubra Cell Wall Skeleton and Silver ions dressing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 31 Dec 2023
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18 to 80 years old (including 18 and 80 years of age), gender not limited;
- in patients with type 2 diabetic foot, in 1999 the WHO diagnostic criteria, diabetic foot screening period or three months before randomization glycated hemoglobin (HbA1C) was detected in 10% or less;
- the target body ankle brachial index of at least 0.8, without intermittent claudication walkers;
- the target ulcer must have the following characteristics: A) according to the Wagner ulcer classification system for level 1 or level 2 B) ulcer is located in the foot, ankle and shin before; C) wound area of 2-5 cm2; D) has existed at least 4 weeks before randomization; E) if you have multiple wounds, select into the set standard and area is one of the biggest intervention and evaluation of the wound.The rest of the wound conventional treatment is not included in the study;If there are two or more wounds are the biggest, choose the worst into classification research;If there are two or more wound area and the classification, choice wound area are the longest study; F) without visible pus and necrotic material;
- voluntary to participate in this clinical study, cooperate a doctor to conduct research, and sign the informed consent.
Who cannot join
- with clear surgical indications, such as vascular occlusion, bone exposed, abscess, osteomyelitis, etc;
- into the group of the first 3 months of vascular reconstruction or angioplasty;
- impaired liver function (ALT and AST 3 times more than normal limit, AST, aspartate amino transferase;ALT: alanine aminotransferase);
- serum creatinine greater than 2 times the upper limit of normal value;
- serum albumin < 2.0 g/dL;
- is undergoing immunosuppressive medication;
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- Various malignant tumor patients ;
- of pregnant women, nursing mothers, or in the near future with family planning; ● with nerve, mental disorders and can't cooperation or unwilling to partners, has a history of alcoholism, drug abuse, and failed to quit;
- into the group of the first 3 months participated in other clinical subjects; Cartesian bacteria cell wall
- to use red, skeleton or silver products are taboo, allergies or known allergies;
- researchers believe that patients should not participate in this study to other situations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Clinical Efficacy and Safety of Topical Nocardia Cell Wall Skeleton in the Treatment of Diabetic Foot Ulcer Wounds- A Prospective, Randomized, Controlled, Multicentre Study
This study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group（silver ions dressing）, with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.
- Conditions
- Diabetic Foot Ulcer, Therapy, Directly Observed
- Being tested
- Nocardia rubra Cell Wall Skeleton, Silver ions dressing
- Keywords
- Diabetic Foot Ulcer, Nocardia Rubra Cell Wall Skeleton
- Medical subject headings
- Diabetic Foot, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocardia rubra Cell Wall SkeletonDrug
Also called Treatment group
Nocardia rubra cell wall skeleton for external application
Silver ions dressingDrug
Also called Control group
Silver ions dressing for external application
| Study group | Role | What they receive |
|---|---|---|
| N-CWS treatment group | Experimental | Patients with N-CWS treatment Receives: Drug: Nocardia rubra Cell Wall Skeleton |
| Control group（ treatment with Silver Ion-releasin) | Placebo comparator | Patients with Silver Ion-releasin Receives: Drug: Silver ions dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing rate up to 30 days
The wound healing rate for 30 days treatment（physiological parameter）
Measured: 30 days after first medicine application
Secondary outcomes (4)
Healing time
The time with complete closure of wound within 30 days treatment
Measured: From date medicine application until the complete closure of wound, assessed up to 30 days
Healing rate
The rate of complete closure of wound for 30 days treatment
Measured: 30 days after first medicine application
Surgical intervention rate
The rate of Surgical intervention for 30 days treatment（physiological parameter）
Measured: From first medicine application to 30 days
Pathogenic bacteria positive rate
The rate of Pathogenic bacteria positive for 30 days treatment（physiological parameter）
Measured: 30 days after first medicine application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start20 May 2022 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulou Hospital Affiliated to Medical College of Nanjing University, Suzhou Municipal Hospital, Affiliated Hospital of Nantong University, Affiliated Hospital of Jiangnan University, Huai'an First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368142
- Sponsor's protocol ID
- XYFY2021-KL151-01
- Status last verified
- Jan 2022
- First submitted
- 27 Jul 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy and Safety of Topical Nocardia Cell Wall Skeleton in the Treatment of Diabetic Foot Ulcer Wounds- A Prospective, Randomized, Controlled, Multicentre Study
- ClinicalTrials.gov ID
- NCT05368142
- Acronym / sponsor ID
- XYFY2021-KL151-01
- Conditions
- Diabetic Foot Ulcer, Therapy, Directly Observed
- Keywords
- Diabetic Foot Ulcer, Nocardia Rubra Cell Wall Skeleton
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Gulou Hospital Affiliated to Medical College of Nanjing University, Suzhou Municipal Hospital, Affiliated Hospital of Nantong University, Affiliated Hospital of Jiangnan University, Huai'an First People's Hospital
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 May 2022 (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 study was to investigate the efficacy and safety of Nocardia rubra Cell Wall Skeleton (NCWS) in the treatment of diabetic foot ulcer wounds. The study was a prospective, randomized, controlled, multicentre study . The subjects were randomly divided into two groups: NCWS group and control group（silver ions dressing）, with a total of 116 cases and 58 cases in each group. Patients in the NCWS group received nocardia rubra cell wall skeleton for external use, in parallel with silver ions dressing treatment. The efficacy and side effects were observed, with a primary endpoint of 30-days wound healing rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-CWS treatment group | Experimental | Drug: Nocardia rubra Cell Wall SkeletonPatients with N-CWS treatment |
| Control group（ treatment with Silver Ion-releasin) | Placebo comparator | Drug: Silver ions dressingPatients with Silver Ion-releasin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ages 18 to 80 years old (including 18 and 80 years of age), gender not limited;
- in patients with type 2 diabetic foot, in 1999 the WHO diagnostic criteria, diabetic foot screening period or three months before randomization glycated hemoglobin (HbA1C) was detected in 10% or less;
- the target body ankle brachial index of at least 0.8, without intermittent claudication walkers;
- the target ulcer must have the following characteristics: A) according to the Wagner ulcer classification system for level 1 or level 2 B) ulcer is located in the foot, ankle and shin before; C) wound area of 2-5 cm2; D) has existed at least 4 weeks before randomization; E) if you have multiple wounds, select into the set standard and area is one of the biggest intervention and evaluation of the wound.The rest of the wound conventional treatment is not included in the study;If there are two or more wounds are the biggest, choose the worst into classification research;If there are two or more wound area and the classification, choice wound area are the longest study; F) without visible pus and necrotic material;
- voluntary to participate in this clinical study, cooperate a doctor to conduct research, and sign the informed consent.
Key exclusion criteria (11 listed)
- with clear surgical indications, such as vascular occlusion, bone exposed, abscess, osteomyelitis, etc;
- into the group of the first 3 months of vascular reconstruction or angioplasty;
- impaired liver function (ALT and AST 3 times more than normal limit, AST, aspartate amino transferase;ALT: alanine aminotransferase);
- serum creatinine greater than 2 times the upper limit of normal value;
- serum albumin < 2.0 g/dL;
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 |
|---|---|---|
| Nocardia rubra Cell Wall SkeletonAlso: Treatment groupNocardia rubra cell wall skeleton for external application | Drug | N-CWS treatment group |
| Silver ions dressingAlso: Control groupSilver ions dressing for external application | Drug | Control group（ treatment with Silver Ion-releasin) |
Primary outcome
Wound healing rate up to 30 days
Time frame: 30 days after first medicine application
The wound healing rate for 30 days treatment（physiological parameter）
4 secondary outcomes
Healing time
Time frame: From date medicine application until the complete closure of wound, assessed up to 30 days
Healing rate
Time frame: 30 days after first medicine application
Surgical intervention rate
Time frame: From first medicine application to 30 days
Pathogenic bacteria positive rate
Time frame: 30 days after first medicine application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nocardia rubra Cell Wall Skeleton and Silver ions dressing in people with Diabetic Foot Ulcer and Therapy, Directly Observed, run by The Affiliated Hospital of Xuzhou Medical University.
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 5 inclusion and 11 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Caiqi Shen (86-15062128691, shencaiqi@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 up to 30 days (time frame: 30 days after first medicine application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2022.