Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
202
Countries
1
Sites
28
Diabetic Foot Ulcer
The primary aim of this trial is to evaluate time to healing. This means to evaluate the efficiency of local antimicrobial agents to bring about complete healing of DFU, diabetic foot ulcer.
Key facts
- Sponsor
- Vaestra Goetalandsregionen, University Of Gothenburg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 9 Dec 2021 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512612-22-00
- EudraCT number
- 2020-001365-36
- ClinicalTrials.gov
- NCT05132179
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Pharmacoeconomic, Efficacy, Therapy, Safety
The primary aim of this trial is to evaluate time to healing. This means to evaluate the efficiency of local antimicrobial agents to bring about complete healing of DFU, diabetic foot ulcer.
Secondary objectives 5
- To evaluate if treatment with HOCl and PHMB in treating DFU differ with respect to proportion of DFU that heals within 12 weeks of treatment.
- To evaluate if treatment with HOCl and PHMB in treating DFU differ with respect to the size of the DFU´s surface area over 24 weeks of treatment.
- To evaluate if treatment with HOCl and PHMB in treating DFU differ with respect to the depth of the DFU over 24 weeks of treatment.
- To evaluate if treatment with HOCl and PHMB in treating DFU differ with respect to use of antibiotics over 24 weeks of treatment.
- To evaluate if treatment with HOCl and PHMB in treating DFU differ with respect to quality of life over 24 weeks of treatment using the EQ-5D questionnaire.
Conditions and MedDRA coding
Diabetic Foot Ulcer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Written and verbal informed consent given before trial-related activities
- Diabetes type 1, type 2 or diabetes due to pancreatitis
- Foot ulcer ≥ 10 days
- Ulcer surface area ≥ 9 mm2
- Age 18 years old or older
Exclusion criteria 15
- Persons in need of intensive care or dialysis.
- Diabetes of MOODY type.
- Current known pregnancy or planned pregnancy during the next 26 weeks by asking the participant.
- For participation in the sub study of 40 patients taking biopsies the DFU shall not be close to a joint, have direct skeletal contact or risk that such an appear and the DFU should not be ground with granular healing tissue.
- Participation in another trial evaluating any treatment.
- Other reasons judged by the investigator that the patient is unsuitable for participation in the study.
- Persons in need of vascular intervention, critically impaired peripheral circulation (toe pressure < 30 mmHg).
- Current treatment of malignancy.
- Event of myocardial infarction or stroke during the last 4 weeks.
- Debut of atrial fibrillation or heart failure (ejection fraction <40 %) during the last 4 weeks.
- Treatment with corticosteroids of a dose corresponding to 50 mg Prednisolone or higher.
- Severe wound infection according to the International Working Group of the Diabetic Foot comprising at least 2 of the following signs: body temperature>38°C or <36°C, heart rate >90 beats/minute, respiration rate >20/minute, LPK>12 x 10^9
- Planned changed residence within the next 26 weeks requiring change of clinic for wound treatment during the follow-up time.
- Age <18 years old.
- If the toe or foot where the DFU is located likely needs amputation in close future or will undergo a spontaneous amputation or need judgement regarding this risk of amputation by further specialist (o.e. the DFU will not be possible to evaluate regarding healing effects)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint variable is difference in the time from baseline (randomization) to healing for patients randomized to treatment with HOCl and PHMB evaluated over 24 weeks of treatment measured as hazard ratio.
Secondary endpoints 5
- Proportion healed DFUs in HOCl group versus PHMB group at week 12.
- The difference in the change of the surface area of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) over 24 weeks.
- The difference in the change of the depth of the DFU for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
- Difference in the mean number of days of antibiotic treatment for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
- Difference in the change of quality of life using the EQ5-D questionnaire for patients treated with HOCl versus PHMB from baseline (randomization) to week 24.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB15292MIG · Substance
- Active substance
- Sodium Hypochlorite
- Pharmaceutical form
- CUTANEOUS SOLUTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 8 ml millilitre(s)
- Max total dose
- 192 ml millilitre(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaestra Goetalandsregionen
- Sponsor organisation
- Vaestra Goetalandsregionen
- Address
- Regionens Hus
- City
- Vänersborg
- Postcode
- 462 80
- Country
- Sweden
Scientific contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Marcus Lind
Public contact point
- Organisation
- Vaestra Goetalandsregionen
- Contact name
- Marcus Lind
University Of Gothenburg
- Sponsor organisation
- University Of Gothenburg
- Address
- P. O. Box 100
- City
- Gothenburg
- Postcode
- 405 30
- Country
- Sweden
Scientific contact point
- Organisation
- University Of Gothenburg
- Contact name
- Marcus Lind
Public contact point
- Organisation
- University Of Gothenburg
- Contact name
- Marcus Lind
Sponsor responsibilities
- Article 77 compliance
- Vaestra Goetalandsregionen
- Contact point sponsor
- Vaestra Goetalandsregionen
- Article 77 implementation
- Vaestra Goetalandsregionen
Locations
1 EU/EEA country · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 202 | 28 |
| Rest of world | — | 0 | — |
Investigational sites
Vaestra Goetalandsregionen
Capio Vårdcentral Strömstad, Regionens Hus, 462 80, Vaenersborg
Region Skane Kristianstad Central Hospital
Medicinkliniken, Centralsjukhuset Kristianstad, J A Hedlunds väg 5, 29185, Kristianstad, J A Hedlunds Vag 5, Kristianstads Heliga Trefaldighet, Kristianstad
Vaestra Goetalandsregionen
Bergsjöns Vårdcentral, Rymdtorget 8D, 415 19 Göteborg, Regionens Hus, 462 80, Vaenersborg
NU Hospital Group-Vastra Gotalandsregionen
NÄL, Clinical Trial Center, Endocrinology/Diabetes, Larketorpsvagen 20, 461 73 Trollhattan, Larketorpsvagen, 461 85, Trollhattan
Lasarettet I Motala Region Ostergotland
Endocrinology/Diabetes, Lasarettsgatan 37, 591 35, Motala
Region Oestergoetland
Endokrinmedicinska kliniken, Universitetssjukhuset Linköping, 581 85 Linköping, Universitetssjukhuset I, 58185, Linkoping
Region Dalarna
Endocrinology/diabetes, Lasarettsvägen 10, Falu Lasarett, Falun, Vasagatan 27, Falu Kristine, Falun
Vaestra Goetalandsregionen
Närhälsan Ljungskile Vårdcentral, Vällebergsvägen 28, 459 30 Ljungskile, Regionens Hus, 462 80, Vaenersborg
NU Hospital Group-Vastra Gotalandsregionen
Uddevalla hospital, Clinical Trial Center, Endocrinology/Diabetes, Fjällvägen 9, 451 53 Uddevalla, Larketorpsvagen, 461 85, Trollhattan
Region Vaesterbotten
Backens Hälsocentral, Manusgränd 3, 901 24, Umeå, Koksvagen 11, Alidhem, Umea
Region Soermland
Endocrinology/Diabetes, Olrogs Väg 1, Nyköpings lasarett, Nyköping, Repslagaregatan 19, 611 32, Nykoping
Region Oerebro Laen
Endokrinologi- och diabetesmottagningen, Örebro universitetssjukhus, Södra grevrosengatan, 70382, Sodra Grev Rosengatan, 701 85, Orebro
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Endocrinology/Diabetes, Östra Sjukhuset, Diagnosvägen 11, 416 50 Göteborg, Diagnosvagen 11, Harlanda, Gothenburg
Region Kronoberg
Centrallasarettet Växjö, Strandvägen 8, 351 85 Växjö, Endocrinology/Diabetes, Nygatan 20, Vaxjo Stads- Och Domkyrkofors., Vaxjo
Region Gaevleborg
Diabetesmottagningen, Gävle sjukhus, Lasarettvägen 1, 80324, Gävle, Rektorsgatan 1, 802 50, Gavle
Region Stockholm – SLSO
Centrum för Diabetes, Solnavägen 1E, 113 65 Stockholm, Solnavagen 1 E, S:t Matteus, Stockholm
Vaestra Goetalandsregionen
Närhälsan Backa Vårdcentral, Rimmaregatan 2, 422 55 Hisings Backa, Regionens Hus, 462 80, Vänersborg
Sjukhusen I Vaester-Vaestra Goetalandsregionen
Angered Hospital, Endocrinology/Diabetes, Halmtorget 1, 424 22 Angered, Halmtorget 1, 424 65, Angered
Region Skane Skanes Universitetssjukhus
Skånes universitetssjukhus Lund, Endocrinology/Diabetes, Entrégatan 7, Lund, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Endocrinology/Diabetes, Mölndals Sjukhus, Göteborgsvägen 31, 431 80 Mölndal, Goteborgsvagen 31, Fassberg, Molndal
Vaestra Goetalandsregionen
Närhälsan Tjörn Vårdcentral, Syster Ebbas väg 1, 47194 Kållekärr, Regionens Hus, 462 80, Vaenersborg
Region Skane Aengelholms Sjukhus
VO Medicin, Ängelholms sjukhus, Södra vägen 3, 28180 Ängelholm, Landshovdingevagen 7e, 262 52, Angelholm
Region Uppsala
CTC, Dag hammarsköldsväg 10B, 75237 Uppsala, Storgatan 27, Uppsala Domkyrkofors, Uppsala
Region Skane Skanes Universitetssjukhus
Diabetesmottagning SUS Malmö, Tora Kjellgrens gata 17, Malmö, St. Johns, Fritz Bauers Gata 5, Malmo
Region Uppsala
Östervåla Vårdcentral, Åbygränd 2, 740 46 Östervåla, Storgatan 27, Uppsala Domkyrkofors, Uppsala
Familjeläkarna i Saltsjöbaden AB
Familjeläkarna i Saltsjöbaden Vårdcentral, Byvägen 52, 13334 Saltsjöbaden, Region Stockholm, Byvägen 52, 133 34, Saltsjöbaden
Capio Närvård AB
Capio Vårdcentral Simrishamn, Sjukhusvägen 1, 272 32, Simrishamn
Capio Legevisitten AB
Capio Legevisitten Säbo, Karlsrovägen 1, 182 53 Danderyd, Brovägen 1, 182 76, Stocksund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2021-12-09 | 2022-01-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512612-22 | 11 |
| Recruitment arrangements - Extract (for publication) | Annons_till_DakinTrial_2024-512612-22-00 | 1 |
| Recruitment arrangements (for publication) | K1_Rekryteringsforfarande_2024-512612-22-00 | 1 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinfo_samtycke_2_Biopsi_2024-512612-22-00 | 2 |
| Subject information and informed consent form (for publication) | L1_Forsokspersonsinformation_samtycke_2024-512612-22 | 8 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dakins losning | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol_synopsis_SE_2024-512612-22-00 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | Sweden | Acceptable 2024-11-05
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-14 | Sweden | Acceptable 2025-04-28
|
2025-05-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-15 | Sweden | Acceptable | 2025-09-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-05 | Sweden | Acceptable | 2026-01-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-24 | Sweden | Acceptable 2026-04-16
|
2026-04-17 |