NCT04186377

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2021

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

December 2, 2019

Last Update Submit

June 6, 2022

Conditions

Diabetic FootNeuropathic Foot UlcerChronic Diabetic Ulcer of Left Foot (Diagnosis)Chronic Diabetic Foot Ulcer of Right Foot

Outcome Measures

Primary Outcomes (1)

  • Change of ulcer surface area

    % change of ulcer surface area

    12 weeks after enrollment in the study

Secondary Outcomes (3)

  • Percentage of completely healed ulcers

    12 weeks after enrollment in the study

  • Incidence of adverse events

    12 weeks after enrollment in the study

  • Incidence of amputations

    12 weeks after enrollment in the study

Study Arms (2)

Standard-of-care managed group

ACTIVE COMPARATOR

This group will receive the optimal standard-of-care for neuropathic/neuroischemic diabetic foot ulcers

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

Other: Standard-of-care for neuropathic/neuroischemic diabetic foot ulcersDrug: S26E

Interventions

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

S26EStandard-of-care managed group
S26EDRUG

Daily application of S26E extract on wound site

S26E

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine

Athens, 11527, Greece

Location

Related Publications (2)

  • 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.

    PMID: 28868224BACKGROUND

  • Silva 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.

    PMID: 29849484BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic FootDisease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 4, 2019

Study Start

May 15, 2020

Primary Completion

November 29, 2021

Study Completion

November 29, 2021

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)