Diabetic FootPhase 2NCT04186377
Application of S26E for Diabetic Foot Ulcer Healing
A Phase 2 study testing Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers and S26E in people with Diabetic Foot and Neuropathic Foot Ulcer, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot, Neuropathic Foot Ulcer, Chronic Diabetic Ulcer of Left Foot (Diagnosis)
- What is being tested?
- Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers and S26E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGreece
- Study dates
- 15 May 2020to 29 Nov 2021
- Phase
- Phase 2
- 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
- Type 1 or type 2 Diabetes Mellitus
- Body Mass Index <40 kg/m2
- Glycated Hemoglobin (HbA1c) <10%
- Presence of a diabetic foot ulcer with the following features i) Owing to chronic peripheral sensorimotor diabetic neuropathy, with or without peripheral arterial disease (critical ischemia excluded as indexed by an Ankle-Brachial index <0.4 ) ii) Persistence for >12 weeks iii) Already following an adequate off-loading method
Who cannot join
- Presence of clinical signs of infection
- Inability or refusal to follow off-loading methods
- Ulcer surface area decline by >15% during the run-in period
- Malignant disease (non-melanoma skin malignancy and healed thyroid malignancies excluded)
- Acute Charcot arthropathy
- Serious chronic Hepatic (Child-Pugh B or C), Renal (stage 4-5 CKD) or Heart (NYHA 3-4) disease
- Known hypersensitivity to the product or its contents
- Any random glucose measurement >350 mg/dl during the run-in period
Trial locations and contacts
1 site in 1 country.
Greece1 site
Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
Athens, 11527
About this study
Official title: A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing
A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.
Read the detailed description
This is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil (S26E) for the healing of non-infected chronic (>12 weeks) diabetic foot ulcers. The S26E is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. The safety of topical S26E application on human skin has been clinically demonstrated.
Eligible participants will be adults patients with diabetes mellitus (DM) type 1 or 2 and chronic (persistent for >12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. Following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. After a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. Participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local S26E application on ulcer (intervention group) (visits 3-12). After visit 12 the application of S26E will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). Efficacy end-points will be assessed at the end of the of 12 weeks of observation (Visit 12)
- Conditions
- Diabetic Foot, Neuropathic Foot Ulcer, Chronic Diabetic Ulcer of Left Foot (Diagnosis), Chronic Diabetic Foot Ulcer of Right Foot
- Being tested
- Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers, S26E
- Medical subject headings
- Diabetic Foot, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-care for neuropathic/neuroischemic diabetic foot ulcersOther
Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing
S26EDrug
Daily application of S26E extract on wound site
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care managed group | Active comparator | This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers Receives: Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers |
| S26E | Experimental | This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers plus daily S26E application Receives: Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers; Drug: S26E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ulcer surface area
% change of ulcer surface area
Measured: 12 weeks after enrollment in the study
Secondary outcomes (3)
Percentage of completely healed ulcers
Percentage of participants to achieve ulcer healing within the observation period
Measured: 12 weeks after enrollment in the study
Incidence of adverse events
Incidence of product-related adverse events (local or systemic infection, local hypersensitivity reactions)
Measured: 12 weeks after enrollment in the study
Incidence of amputations
Number of patients that required an amputation
Measured: 12 weeks after enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start15 May 2020
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Why it stopped: Inability to recruit subjects
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 FootStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186377
- Sponsor's protocol ID
- S26E for neuropathic ulcers
- Status last verified
- Jun 2022
- First submitted
- 2 Dec 2019
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheikhyoussef N, Kandawa-Schulz M, Bock R, de Koning C, Cheikhyoussef A, Hussein AA. Characterization of Acanthosicyos horridus and Citrullus lanatus seed oils: two melon seed oils from Namibia used in food and cosmetics applications. 3 Biotech. 2017 Oct;7(5):297. doi: 10.1007/s13205-017-0922-3. Epub 2017 Aug 31.
PubMed 28868224Silva JR, Burger B, Kuhl CMC, Candreva T, Dos Anjos MBP, Rodrigues HG. Wound Healing and Omega-6 Fatty Acids: From Inflammation to Repair. Mediators Inflamm. 2018 Apr 12;2018:2503950. doi: 10.1155/2018/2503950. eCollection 2018.
PubMed 29849484
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing
- ClinicalTrials.gov ID
- NCT04186377
- Acronym / sponsor ID
- S26E for neuropathic ulcers
- Conditions
- Diabetic Foot, Neuropathic Foot Ulcer, Chronic Diabetic Ulcer of Left Foot (Diagnosis), Chronic Diabetic Foot Ulcer of Right Foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit subjects
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 4 Dec 2019 (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.
A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.
Detailed description
This is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil (S26E) for the healing of non-infected chronic (>12 weeks) diabetic foot ulcers. The S26E is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. The safety of topical S26E application on human skin has been clinically demonstrated.
Eligible participants will be adults patients with diabetes mellitus (DM) type 1 or 2 and chronic (persistent for >12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. Following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. After a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. Participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local S26E application on ulcer (intervention group) (visits 3-12). After visit 12 the application of S26E will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). Efficacy end-points will be assessed at the end of the of 12 weeks of observation (Visit 12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care managed group | Active comparator | Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcersThis group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers |
| S26E | Experimental | Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers, Drug: S26EThis group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers plus daily S26E application |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or type 2 Diabetes Mellitus
- Body Mass Index <40 kg/m2
- Glycated Hemoglobin (HbA1c) <10%
- Presence of a diabetic foot ulcer with the following features i) Owing to chronic peripheral sensorimotor diabetic neuropathy, with or without peripheral arterial disease (critical ischemia excluded as indexed by an Ankle-Brachial index <0.4 ) ii) Persistence for >12 weeks iii) Already following an adequate off-loading method
Key exclusion criteria (8 listed)
- Presence of clinical signs of infection
- Inability or refusal to follow off-loading methods
- Ulcer surface area decline by >15% during the run-in period
- Malignant disease (non-melanoma skin malignancy and healed thyroid malignancies excluded)
- Acute Charcot arthropathy
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 |
|---|---|---|
| Standard-of-care for neuropathic/neuroischemic diabetic foot ulcersOptimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing | Other | S26E, Standard-of-care managed group |
| S26EDaily application of S26E extract on wound site | Drug | S26E |
Primary outcome
Change of ulcer surface area
Time frame: 12 weeks after enrollment in the study
% change of ulcer surface area
3 secondary outcomes
Percentage of completely healed ulcers
Time frame: 12 weeks after enrollment in the study
Incidence of adverse events
Time frame: 12 weeks after enrollment in the study
Incidence of amputations
Time frame: 12 weeks after enrollment in the study
Results and safety
The study was stopped early (reason given: Inability to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Background: PubMed 28868224Cheikhyoussef N, Kandawa-Schulz M, Bock R, de Koning C, Cheikhyoussef A, Hussein AA. Characterization of Acanthosicyos horridus and Citrullus lanatus seed oils: two melon seed oils from Namibia used in food and cosmetics applications. 3 Biotech. 2017 Oct;7(5):297. doi: 10.1007/s13205-017-0922-3. Epub 2017 Aug 31.
- Background: PubMed 29849484Silva JR, Burger B, Kuhl CMC, Candreva T, Dos Anjos MBP, Rodrigues HG. Wound Healing and Omega-6 Fatty Acids: From Inflammation to Repair. Mediators Inflamm. 2018 Apr 12;2018:2503950. doi: 10.1155/2018/2503950. eCollection 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers and S26E in people with Diabetic Foot and Neuropathic Foot Ulcer, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 8 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: stopped early, as of the sponsor's last update on 8 Jun 2022. 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 Greece. 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.
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?
The study was stopped early (reason given: Inability to recruit subjects). Results are not available in the source record.
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?
Change of ulcer surface area (time frame: 12 weeks after enrollment in the study). 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 NCT04186377, 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 8 Jun 2022.