Diabetic foot ulcer infection prevention study
| ISRCTN | ISRCTN72107594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72107594 |
| IRAS number | 347528 |
| Secondary identifying numbers | C3206, CPMS 60798 |
- Submission date
- 29/01/2025
- Registration date
- 03/02/2025
- Last edited
- 11/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Wound infections are one of the risk factors leading to diabetic foot ulcer deterioration, burdensome follow-up treatments, and toe/foot amputation. Infection prevention and management is therefore a key aspect in treating such wounds. The capability of the study products to prevent infection has been investigated mainly in acute wounds. This study aims to gain more insight into this preventive effect in hard-to-heal wounds, e.g., diabetic foot ulcers.
Who can participate?
Adult patients with diabetes and an ulcer (neuropathic, ischemic, and/or neuroischaemic)
What does the study involve?
Study participation is planned to be 12 weeks. During this time, participants are expected to come to the study site 4 times for examinations and to participate in 9 short study examinations during routinely scheduled dressing changes and/or wound inspections. During each of these study visits, the wound will be examined for various criteria (signs of infection, size of the wound, and wound pain etc.). At the beginning of the study, participants will be randomly allocated into one of the two study groups (arms) (one arm being the control arm which is the common standard of care and the second arm being the test group in which the study products will be used in addition to to the standard-of-care). The study products have been used in wound care for several years. In addition, participants will at the study start and end be asked to complete a quality-of-life questionnaire. Further, they will be asked questions about treatment experiences and satisfaction at the final study visit.
What are the possible benefits and risks of participating?
Possible benefits for you: Both products have been successfully used in wound care for a long time. In both study arms the standard of care will be used to treat the wound. This ensures that in the context of this study, regardless of which group participants are in, they will always receive wound care that meets the common medical standard. During your study participation, data will be collected to help improve the care of this type of wound in the future. They may not necessarily be able to see these benefits for themselves during the study but may help future patients who are being treated for similar wounds.
Potential risks and exposures: The products used in this study have been approved worldwide for a long time, and there already exists a lot of data on safety and tolerability. Experience with the products in the past does not show an increased incidence of undesirable side effects and the general risk is estimated to be very low. Nevertheless, risks in treatment with wound dressings can never be completely ruled out: allergic reactions may occur, and redness or itching could require additional treatment.
Where is the study run from?
University Hospitals of Derby and Burton NHS Foundation Trust, UK
When is the study starting and how long is it expected to run for?
May 2024 to December 2026
Who is funding the study?
BSN medical GmbH
Who is the main contact?
Dr Hardy Schweigel, hardy.schweigel@essity.com
Contact information
Public, Scientific
BSN medical GmbH
Schützenstraße 1-3
Hamburg
22761
Germany
| Phone | +4915227752954 |
|---|---|
| hardy.schweigel@essity.com |
Principal Investigator
3 Blackburn Street
Manchester
M251FT
United Kingdom
| Phone | +4915227752954 |
|---|---|
| paul.chad@live.co.uk |
Study information
| Study design | Postmarket multicenter randomized controlled parallel-arm open-label adaptive study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Other therapist office, Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Prospective, multicenter, parallel, open-label, randomized, controlled trial to investigate the ability of Cutimed® Sorbact® to decrease the risk of infections in subjects with non-infected diabetic foot ulcers compared to standard of care |
| Study objectives | The primary statistical hypothesis evaluated in this study relates to the primary endpoint. The null and alternative hypothesis are given by: H0: Among patients with diabetic foot ulcers (DFUs), the proportion of DFUs that become infected over a 12-week treatment period is equal between those treated with Sorbact® in addition to standard of care (SOC) and those under SOC alone. H1: Among patients with DFUs, the proportion of DFUs that become infected over a 12-week treatment period is lower for patients treated with Sorbact® in addition to SOC compared to those under SOC alone. |
| Ethics approval(s) |
Approved 30/01/2025, London - Dulwich Research Ethics Committee (80 London Road, London, SE1 6LH, United Kingdom; +44 (0)207 104 8290; dulwich.rec@hra.nhs.uk), ref: 24/LO/0889 |
| Health condition(s) or problem(s) studied | Non-infected superficial diabetes-related foot ulcers |
| Intervention | The investigation aims to evaluate the preventive effect of Sorbact® gel dressing and Sorbact® swab when used in conjunction with standard of care (SOC) compared with the control arm SOC. Control: Treatment of diabetic foot ulcer according to SOC as described in NICE guideline NG-19. Test: Treatment of the ulcer using a monolayer of a dialkylcarbomoyl chloride (DACC)-coated wound dressing (Sorbact Swab or Sorbact Gel) plus the standard-of-care as defined in NICE guideline NG-19. In both arms, treatments will be done whenever medically needed, study documentation is updated weekly. Randomization: The treatments are randomised within blocks with variable sizes. The respective block sizes are themselves randomised to avoid prediction. Study participation is planned to be 12 weeks. During this time, participants are expected to come to the study site 4 times for examinations and to participate in 9 short study examinations during routinely scheduled dressing changes and/or wound inspections. During each of these study visits, the wound will be examined for various criteria (signs of infection, size of the wound, and wound pain etc.). At the beginning of the study, participants will be randomly allocated into one of the two study groups (arms) (one arm being the control arm which is the common standard of care and the second arm being the test group in which the study products will be used in addition to to the standard-of-care). The study products have been used in wound care for several years. In addition, participants will at the study start and end be asked to complete a quality-of-life questionnaire. Further, they will be asked questions about treatment experiences and satisfaction at the final study visit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cutimed® Sorbact® |
| Primary outcome measure | Infections in non-infected diabetic foot ulcers (DFUs) measured by a clinician using the International Working Group on the Diabetic Foot (IWGDF) criteria for wound infection at baseline, and weeks 4,8 and 12 |
| Secondary outcome measures | 1. Infection signs and description, as defined by the IWGDF guideline 2023, measured by a clinician weekly and an assessment of general wound pain measured using a visual analogue scale (VAS) at baseline, and weeks 4, 8 and 12 2. Changes to the wound including the appearance of the wound and peri-wound skin as well as the wound size measured by a clinician with a wound ruler at baseline, and weeks 4, 8 and 12 3. Sorbact® device use in the test arm measured by self-reporting of the dressing used and dressing change frequency at baseline, and weeks 4, 8 and 12 4. Health-related quality of life measured using the EQ-5D-5L questionnaire at baseline and week 12, with satisfaction measured at the final visit only 5. Healthcare provider's (HCPs) assessment of treatment success and HCPs satisfaction measured using self-reporting at week 12 6. Sorbact® device safety measured by self-reporting device deficiencies at every study visit |
| Overall study start date | 01/05/2024 |
| Completion date | 21/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 550 enrolled |
| Key inclusion criteria | General criteria: 1. At least 18 years old 2. The subject understands and is willing to participate in the clinical study (written informed consent) and can comply with required visits 3. The subject has diabetes and an ulcer (neuropathic, ischemic, and/or neuroischaemic) 4. Diagnosis of either type I or type II diabetes with glycosylated haemoglobin HbA1c ≤ 108 (12%) 5. The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study 6. The target ulcer is planned to undergo standard wound care (SWC) therapy Ulcer criteria: 1. Non-infected according to IWGDF 2023 2. WIFI (Wound 1, Ischemia 0,1,2 and Infection 0) 3. Wound area > 1 cm2 4. Ulcer not older than 12 weeks 5. Superficial ulcer not involving tendon, capsule or bone 6. Systemic and/or topical antibiotic treatment wash out of at least 48 hours) 7. Treatment with any antimicrobial dressing wash out of at least 7 days |
| Key exclusion criteria | 1. Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes. 2. Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. 3. Eligible DFU has associated untreated acute or chronic osteomyelitis or abscess. 4. Clinically infected ulcer (IWGDF 2023: ≥ 2 signs of infection) 5. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy. 6. Pregnant or breast-feeding patients 7. Subject not deemed suitable by the principle investigator for another reason. 8. Sensitivity or allergy to any product component. 9. Participation in another pharmaceutical or medical device study within the last 30 days. 10. Employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc. |
| Date of first enrolment | 01/04/2025 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Sponsor information
Industry
Schützenstraße 1-3
Hamburg
22761
Germany
| Phone | +46761077156 |
|---|---|
| markus.wittebo@essity.com | |
| Website | https://www.essity.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 21/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (https://www.castoredc.com/) |
Editorial Notes
11/03/2025: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/03/2025 to 01/04/2025.
04/03/2025: Internal review.
31/01/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
