The WARM Study is a Pilot Study That Aims to Investigate the Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg.

NCT07640672 | Not Yet Recruiting

• 1 other identifier: 25-0578
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study. The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital. In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital. Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.

Conditions

Homeless Persons; Wound and Injuries; Chronic Wound Care; Homelessness; Environmental Health; Environmental Factors; Psychiatric Disorders; Drug Abuse/Dependence

Keywords

wound care; environmental health; wound and injuries; homeless persons; psychiatric disorders; drug abuse/dependence

Outcome Measures

Primary Outcomes (4)

• Identification of the positive and negative effects of environmental factors on the onset, progression and recovery from of chronic wounds among homeless people who use the Johanniter-Hilfsmobil in Augsburg

  To answer the research question, the following data will be collected from study participants via a questionnaire and clinical examination: * Wound area and volume (wound length in cm, wound width in cm, wound area in cm², wound depth in cm), * Qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and conducting the corresponding laboratory tests (incubation on culture media) * Determination of the cause of the wounds (for example caused by cold or heat) through medical history and clinical examination * Assessment of nutritional status by calculating the body mass index (kg/m²) * Assessment of existing cardiovascular risk factors (for example hypertension, or tobacco use) * Vascular assessment, including examination of the pulse status in the lower limbs and if pathological findings are observed non-invasive vascular imaging is performed using the ankle-brachial index and colour-coded duplex sonography

  0-365 days

• Identification of a discrepancy between the substance subjectively perceived to have been consumed and the substance objectively detectable in drug-dependent homeless individuals

  In order to identify any discrepancies between the substance the study participant subjectively believes they have consumed and the substance objectively detected, saliva tests are carried out which are chemically analysed in the laboratory for the presence of the following groups of substances: * Amphetamines and derivatives * Benzodiazepines * Cocaine and cocaine metabolites * Cannabinoids * Other substances (including ketamine) * Synthetic cannabinoids To determine the substance the participant subjectively perceives to have consumed, a questionnaire is administered to assess the participant's current substance use.

  0 - 365 days

• Assessing the impact of environmental factors on the psychosocial circumstances of users of the Johanniter mobile support service.

  Quantitative analysis of the psychosocial circumstances of users of the Johanniter-Hilfsmobil due to exceptional environmental influences, using a standardised questionnaire. The following metrics are to be collected: * Life circumstances index (material situation, gainful employment, housing, health, safety, participation/social networks) * Environmental factors and weather conditions (heat/cold, precipitation, wind, air quality, noise, litter/unhygienic conditions) * Opportunities for a healthy lifestyle (diet, access to drinking water, sleep, recovery) * Use of public spaces and urban infrastructure (mobility, participation, defensive architecture) * Experiences of loneliness * Experiences with and access to the medical and psychosocial care system.

  0 - 365 days

• Survey of the psychosocial circumstances and the environmental factors of which they are exposed of homeless people in Augsburg using the Johanniter-Hilfsmobil

  As a final step, a qualitative analysis will be carried out through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings regarding their psychosocial circumstances and the environmental factors to which they are exposed. The following categories will be covered in the personal interview with the homeless persons: * General living situation * Public spaces and urban infrastructure * Environmental influences and weather conditions * Health * Social support * Medical, psychological and social care

  0-365 days

Other Outcomes (1)

• Difference in consumption patterns in relation to the season

  0 - 365 days

Study Arms (4)

Saliva testing

NO INTERVENTION

Semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted on drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital.

Wound Care Treatment

EXPERIMENTAL

A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those in patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. Furthermore, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded.

Other: Wound care at the University Hospital and in the Johanniter mobile wound care unit

Questionnaire on psychosocial life situation

NO INTERVENTION

The quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardised questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, rubbish/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system.

Guided interview on psychosocial circumstances

NO INTERVENTION

A qualitative analysis will be conducted through guided interviews with up to 15 users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.

Interventions

Wound care at the University Hospital and in the Johanniter mobile wound care unit OTHER

A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. The influence of environmental factors, comorbidities and nutritional status on wound healing and the effects of the dressing sets provided as part of the study on the healing process of the wounds will also be analysed.

Wound Care Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Existing capacity to consent to participation in the study, which will be verified and documented by the study physicians
• Written consent to participate in the study has been obtained from the test subject.

You may not qualify if:

• Minderjährigkeit
• Fehlende schriftliche Einwilligung zur Studienteilnahme
• Instabiler somatischer Zustand der Betroffenen
• Akute Selbst- und Fremdgefährdung

Sponsors & Collaborators

• University Hospital Augsburg: lead
• University of Applied Science Augsburg, Germany: collaborator
• Department of Psychiatry, Psychotherapie and Psychosomatics, Medical Faculty, University of Augsburg, Germany: collaborator

Study Sites (1)

University Hospital Augsburg

Augsburg, Bavaria, 86156, Germany

Location

Related Publications (1)

• 1. Gerull S. Systematische Lebenslagenuntersuchung wohnungsloser Menschen 2018 [Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/246 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-2465. 2. Gerull S. Wohnungslos in unsicheren Zeiten 2022 [1-57]. Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/496 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-4961. 3. Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness:Confirmatory Tests on Survey Data. Research on Aging. 2006;28(5):582-98.

  BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Mental Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is divided into four different study arms. Up to 100 participants are to be included in each study arm. The study arms are intended to lead to scientific insights in the field of wound treatment, substance use and the psychosocial living conditions of homeless people.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)